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FDA 510(k)

KEELER SLIT LAMP H-SERIES

K-Number: K131589 · 2013-06-27

ApplicantKeeler, Ltd.
Decision Date2013-06-27
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER SLIT LAMP H-SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Keeler, Ltd.. It received FDA 510(k) clearance on 2013-06-27 under 510(k) number K131589. 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 KEELER SLIT LAMP H-SERIES?

KEELER SLIT LAMP H-SERIES is a medical device that received FDA 510(k) clearance on 2013-06-27. The listed applicant is Keeler, Ltd.. The 510(k) number is K131589.

When did KEELER SLIT LAMP H-SERIES receive FDA 510(k) clearance?

KEELER SLIT LAMP H-SERIES received FDA 510(k) clearance on 2013-06-27, under 510(k) number K131589.

Who is the listed applicant for KEELER SLIT LAMP H-SERIES?

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

What is the FDA product code for KEELER SLIT LAMP H-SERIES?

The FDA product code for KEELER SLIT LAMP H-SERIES is HJO.

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Other records listing Keeler, Ltd. 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.

K131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESK093445KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)

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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