Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

904 SLIT LAMP

K-Number: K953965 · 1995-09-27

ApplicantClement Clarke, Inc.
Decision Date1995-09-27
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

904 SLIT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Clement Clarke, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K953965. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 904 SLIT LAMP?

904 SLIT LAMP is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Clement Clarke, Inc.. The 510(k) number is K953965.

When did 904 SLIT LAMP receive FDA 510(k) clearance?

904 SLIT LAMP received FDA 510(k) clearance on 1995-09-27, under 510(k) number K953965.

Who is the listed applicant for 904 SLIT LAMP?

The FDA 510(k) record lists Clement Clarke, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 904 SLIT LAMP?

The FDA product code for 904 SLIT LAMP is HJO.

Other records listing Clement Clarke, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961512PERKINS HAND-HELD APPLANATION TONOMETERK952713MINI WRIGHT LR AFSK932258OPTICOM M600K914126VMX MINI-LOG FLOWMETERK914896FRIEDMANN ANALYSER 3K912397PROFESSIONAL INDIRECT OPHTHALMOSCOPE

View all 10 devices →

Related Devices (Code: HJO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262637SLIT LAMP SL-D4 (Type: LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑