FDA 510(k) Premarket Notification K870750: KEELER PULSAIR NON CONTACT TONOMETER

Submission Details & Decision

Normalized public record details for 510(k) notification K870750.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K870750

Applicant / Sponsor

Keeler Instruments, Inc.

Device Name

KEELER PULSAIR NON CONTACT TONOMETER

Product Code

HKX

Decision Date

1987-03-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Traditional

Third Party Flag

Date Received

1987-02-25

Related Establishments / Registrations

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KEELER LTD. Registration: 1000391004 View Registration
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NIDEK INCORPORATED Registration: 2936921 View Registration
NIDEK CO., LTD. HAMACHO PLANT Registration: 3002807715 View Registration
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VISIONIX LTD. Registration: 3003771740 View Registration
CANON COMPONENTS, INC. Registration: 3004026651 View Registration
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Sterigenics Belgium Fleurus SA Registration: 3004681519 View Registration
Industria Optica Rodenstock Chile S. A Registration: 3004848970 View Registration
FREY SPOLKA JAWNA Registration: 3005301392 View Registration
Icare Finland Oy Registration: 3005324856 View Registration
TREVI TECHNOLOGY Registration: 3005771344 View Registration
YELATMA INSTRUMENT-MAKING ENTERPRISE Registration: 3007075140 View Registration
RODENSTOCK CR S.R.O. Registration: 3008396732 View Registration
Topcon Yamagata Co., LTD Registration: 3008729548 View Registration
LUNEAU TECHNOLOGY OPERATIONS Registration: 3009173773 View Registration
VALUKUMPU OY Registration: 3009496855 View Registration
CRYSTALVUE MEDICAL CORPORATION Registration: 3010000450 View Registration
Rodenstock GmbH Registration: 3010069263 View Registration
ESSILOR International Usine de la Compasserie Registration: 3010227033 View Registration
MARIACHI OY Registration: 3010287677 View Registration
MEDIMAGING INTEGRATED SOLUTION INC. Registration: 3015316279 View Registration
OCULUS Florida Service Center Registration: 3020723591 View Registration
OCULUS, INC. Registration: 3033566 View Registration
CARL ZEISS MEDITEC AG (JENA) Registration: 3038356864 View Registration
Canon.Inc Registration: 3038614464 View Registration
NIDEK CO., LTD. Registration: 8030392 View Registration
OCULUS OPTIKGERATE GMBH Registration: 9611269 View Registration
INAMI & CO., LTD. Registration: 9612297 View Registration
TOPCON CORP. Registration: 9614661 View Registration
Carl Zeiss Meditec AG (Jena) Registration: 9615030 View Registration
HUVITZ CO., LTD. Registration: 9616199 View Registration
CARL ZEISS VISION GMBH Registration: 9617474 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.