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FDA 510(k)

PSL CLASSIC SLIT LAMP

K-Number: K100500 · 2010-03-09

ApplicantKeeler Instruments, Inc.
Decision Date2010-03-09
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PSL CLASSIC SLIT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 2010-03-09 under 510(k) number K100500. 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 PSL CLASSIC SLIT LAMP?

PSL CLASSIC SLIT LAMP is a medical device that received FDA 510(k) clearance on 2010-03-09. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K100500.

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

PSL CLASSIC SLIT LAMP received FDA 510(k) clearance on 2010-03-09, under 510(k) number K100500.

Who is the listed applicant for PSL CLASSIC SLIT LAMP?

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

What is the FDA product code for PSL CLASSIC SLIT LAMP?

The FDA product code for PSL CLASSIC SLIT LAMP is HJO.

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Other records listing Keeler Instruments, Inc. as applicant

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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.

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