FDA 510(k) Premarket Notification K760996: HEARING AID (MODEL 695D, 905 & 960P)

Submission Details & Decision

Normalized public record details for 510(k) notification K760996.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K760996

Applicant / Sponsor

Unitron Industries, Inc.

Device Name

HEARING AID (MODEL 695D, 905 & 960P)

Product Code

ESD

Decision Date

1976-11-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

1976-11-08

Related Establishments / Registrations

Magnatone Hearing Aid Corp. dba Persona Medical Registration: 1044692 View Registration
AUDINA HEARING INSTRUMENT, INC Registration: 1052698 View Registration
EAR TECHNOLOGY CORPORATION Registration: 1056339 View Registration
GLOBAL TV CONCEPTS, LTD. Registration: 1063974 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
JKR LABORATORIES, INC. Registration: 1929340 View Registration
Starkey Laboratories, Inc. Registration: 2125608 View Registration
GN Hearing Care Corporation Registration: 2182204 View Registration
STARKEY GLENCOE Registration: 2183732 View Registration
PRAIRIE LABS Registration: 2184059 View Registration
OTICON, INC. Registration: 2240713 View Registration
WS Audiology USA, Inc. Registration: 2430101 View Registration
Hearing Lab Technology, LLC. Registration: 2523532 View Registration
MICROSONIC, INC. Registration: 2523819 View Registration
TECHNIMEN SKILLERS Registration: 3001620590 View Registration
STARKEY DE MEXICO, S.A. DE C.V. Registration: 3002159143 View Registration
Unitron Hearing, a division of National Hearing Services Inc. Registration: 3002808415 View Registration
GN RESOUND CHINA, LTD. Registration: 3003303986 View Registration
Dreve Otoplastik GmbH Registration: 3003610251 View Registration
INNOVATION MEDITECH GMBH Registration: 3004003391 View Registration
TEAM PRECISION PUBLIC COMPANY LIMITED Registration: 3004582233 View Registration
Sonova Hearing (Suzhou) Co., Ltd. Registration: 3004929038 View Registration
DIGIMAX INNOVATIVE PRODUCTS LTD Registration: 3005053820 View Registration
Sonova AG Registration: 3005085999 View Registration
Oticon A/S Registration: 3005465494 View Registration
Natus Manufacturing Limited Registration: 3005581270 View Registration
GN Hearing A/S Registration: 3005650109 View Registration
ALPS INTERNATIONAL Registration: 3005785669 View Registration
AUDIFON - GMBH & CO.KG Registration: 3006076696 View Registration
Sonova Operations Center Vietnam Company Ltd Registration: 3006312495 View Registration
STARKEY (Suzhou) Hearing Technology Co, LTD. Registration: 3006544364 View Registration
Shenzhen Pango Medical Electronics Co., Ltd Registration: 3006792041 View Registration
MG DEVELOPPEMENT Registration: 3006979687 View Registration
DREVE AMERICA CORP. Registration: 3007277229 View Registration
Oticon Medical AB Registration: 3007367732 View Registration
XIAMEN NEWSOUND TECHNOLOGY CO., LTD Registration: 3007694978 View Registration
SAFERLIFE PRODUCTS CO.,LTD. Registration: 3008264111 View Registration
Shandong Huge Dental Material Corporation Registration: 3008320092 View Registration
AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD Registration: 3008606477 View Registration
KENYON AUDIOLOGY Registration: 3008713760 View Registration
Sonova USA Inc. Registration: 3008848788 View Registration
Demant Operations Poland Sp. z o.o. Registration: 3009307953 View Registration
GOLDEN AIM INTERNATIONAL LTD Registration: 3009523076 View Registration
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. Registration: 3009617411 View Registration
JIANGSU BETTERLIFE MEDICAL CO., LTD. Registration: 3010197022 View Registration
FOSHAN VOHOM TECHNOLOGY CO., LTD. Registration: 3010354914 View Registration
XIAMEN RETONE HEARING TECHNOLOGY CO., LTD. Registration: 3010408889 View Registration
MG Development America Inc. Registration: 3010602043 View Registration
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. Registration: 3011350813 View Registration
Huizhou Jinghao Medical Technology Co., Ltd Registration: 3011586575 View Registration
GN ReSound (Malaysia) Sdn Bhd. Registration: 3011927597 View Registration
HEARING LAB TECHNOLOGY, LLC Registration: 3012213704 View Registration
SANICURE BV Registration: 3012494290 View Registration
ZHONGSHAN GREAT-EARS ELECTRONIC TECHNOLOGY CO.,LTD Registration: 3013596029 View Registration
NUVOMED INC Registration: 3014449259 View Registration
XIAMEN MELOSOUND TECHNOLOGY CO.,LTD Registration: 3014844046 View Registration
PRO3DURE MEDICAL GMBH Registration: 3014888923 View Registration
KANGFU MEDICAL EQUIPMENT FACTORY Registration: 3015140207 View Registration
GUANGZHOU NUONING MEDICAL SUPPLIES CO.,LTD Registration: 3015495690 View Registration
SHENZHEN SHENRUI MEDICAL CO. LTD Registration: 3015763534 View Registration
EARTEKNIK ISITME VE ODIOMETRI CIHAZLARI SAN. VE TIC. A.S Registration: 3015990335 View Registration
GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD. Registration: 3016171795 View Registration
ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY Registration: 3016587556 View Registration
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD Registration: 3016630774 View Registration
SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD Registration: 3017207990 View Registration
XIAMEN FORSOUND HEARING TECHNOLOGY CO.,LTD. Registration: 3017293064 View Registration
Demant Operations, S.a. De C.v. Registration: 3017441596 View Registration
HONG YU KANG TECHNOLOGY (GUANGDONG) CO., LTD. Registration: 3017610929 View Registration
HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD Registration: 3017618900 View Registration
KUNWEI MEDICAL ELECTRONICS CO.,LTD Registration: 3017903826 View Registration
GUANGZHOU NEW DESIGN BIOTECHNOLOGY CO., LTD. Registration: 3017910381 View Registration
FLOW-MED GMBH Registration: 3018094156 View Registration
MINAMI MEDICAL TECHNOLOGY (GUANGDONG) CO.,LTD. Registration: 3018999226 View Registration
Tomore Medical (Shenzhen) Co., Ltd Registration: 3019414808 View Registration
Starkey Global Distribution Center Registration: 3019622583 View Registration
WS Audiology Mexico S.A. de C.V. Registration: 3019918054 View Registration
XIAMEN REALINK HEARING TECHNOLOGY CO., LTD Registration: 3020998569 View Registration
Xiamen Mirasing Technology Co., Ltd. Registration: 3021334102 View Registration
Zhongrui HearJoy Medical Equipment co., Ltd. Registration: 3022507139 View Registration
GOODMI INTELLIGENT (SHENZHEN) CO.,LTD. Registration: 3023007429 View Registration
SHENZHEN TONYCORE TECHNOLOGY CO.,LTD. Registration: 3025427079 View Registration
GN ReSound (Malaysia) Sdn. Bhd Registration: 3026048380 View Registration
AHA TECHNOLOGIES, INC. Registration: 3026940243 View Registration
GUANGDONG SOUTHVO MEDICAL TECHNOLOGY CO.,LTD Registration: 3027344214 View Registration
Sonova North American Operations Center S.A.de C.V Registration: 3027487235 View Registration
HEALTH SOURCE MEDICAL EQUIPMENT (GUANGDONG) LTD. Registration: 3027643666 View Registration
SUZHOU SHANGCHUANG TECHNOLOGY SERVICE CO., LTD. Registration: 3030220356 View Registration
XIAMEN VIENATONE MEDICAL TECHNOLOGY CO., LTD. Registration: 3030396448 View Registration
HEYUAN XUANYIN TECHNOLOGY CO., LTD. Registration: 3030497233 View Registration
GUANGDONG JIAJIANLE TECHNOLOGY CO., LTD. Registration: 3030535004 View Registration
WEHEAR INNOVATIONS PRIVATE LIMITED' Registration: 3032954841 View Registration
Natus Sensory Ireland Ltd Registration: 3034880867 View Registration
ONLYCARE INC Registration: 3035374295 View Registration
SONOVA SERVICE CENTER UK LIMITED Registration: 3036679760 View Registration
ZHONGSHAN TIANLE HEARING TECHNOLOGY CO.,LTD Registration: 3037001880 View Registration
POLYSTAR TECHNOLOGY DEVELOPMENT LIMITED Registration: 3043178566 View Registration
OSEL DEVICES LIMITED Registration: 3044828933 View Registration
XIAOWE SOUND TECHNOLOGY (SHENZHEN) CO.,LTD. Registration: 3044987676 View Registration
WS Audiology A/S Registration: 8021514 View Registration
Natus Medical Denmark ApS Registration: 9612197 View Registration
DETAX GMBH Registration: 9680954 View Registration

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