FDA 510(k) Premarket Notification K052795: PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30

Submission Details & Decision

Normalized public record details for 510(k) notification K052795.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K052795

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30

Product Code

HGM

Decision Date

2005-12-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Obstetrics/Gynecology (OB)

Clearance Type

Special

Third Party Flag

Date Received

2005-10-03

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
LEBANESE INTERNATIONAL TECHNOLOGIES Registration: 1000576299 View Registration
HUNTLEIGH HEALTHCARE LTD. Registration: 1000589001 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
AMERICAN I.V. PRODUCTS, INC. Registration: 1121996 View Registration
Philips North America LLC Registration: 1218950 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
MEDGYN PRODUCTS, INC. Registration: 1450908 View Registration
KATECHO LLC Registration: 1930027 View Registration
CLINICOMP INTL., INC. Registration: 2028916 View Registration
R & D BATTERIES, INC. Registration: 2132111 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
BIONET CO., LTD. Registration: 3003681187 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
CETRO AMERICA Registration: 3004167720 View Registration
CLINICAL COMPUTER SYSTEMS, INC. Registration: 3004423584 View Registration
GE HEALTHCARE Registration: 3004526608 View Registration
LUEN HING TEXTILE -Shangyu Manufacturing(ZHONG SHAN) CO LTD Registration: 3004566918 View Registration
AirStrip Technologies, Inc. Registration: 3006104191 View Registration
Bistos co., ltd. Registration: 3006179052 View Registration
CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD. Registration: 3007048259 View Registration
AccuMed Corp. Registration: 3007309299 View Registration
TIOGA LIMITED Registration: 3007607999 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
TENACORE LLC Registration: 3008403701 View Registration
QUIPMENT Registration: 3008717264 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
EDAN Diagnostics, Inc. Registration: 3009499478 View Registration
MEDISONO, LLC Registration: 3010390468 View Registration
B'ORZE INC Registration: 3010395077 View Registration
Natus Neurology Incorporated Registration: 3010611950 View Registration
GWW Registration: 3010698831 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
Philips North America LLC Registration: 3012528160 View Registration
WATCHCHILD, LLC Registration: 3013400897 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Cerner Corporation Registration: 3013546957 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
ORANTECH INC. Registration: 3013783488 View Registration
Datex-Ohmeda, Inc. Registration: 3014220748 View Registration
Philips Medical Systems Ltda Registration: 3014541700 View Registration
SIBEL HEALTH INC. Registration: 3015529350 View Registration
Philips North America LLC Registration: 3016618143 View Registration
Philips North America LLC Registration: 3016701404 View Registration
HUBDIC USA INC Registration: 3021635975 View Registration
Datex-Ohmeda, Inc. Registration: 3036470679 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
PeriGen Solutions Ltd. Registration: 9615396 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
Nicolay GMBH Registration: 9681377 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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