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FDA 510(k)

LED LAMP OR OTHER

K-Number: K092883 · 2009-12-18

ApplicantIntravista Medical Systems, Inc.
Decision Date2009-12-18
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LED LAMP OR OTHER is the device name listed in this FDA 510(k) record. The listed applicant is Intravista Medical Systems, Inc.. It received FDA 510(k) clearance on 2009-12-18 under 510(k) number K092883. 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 LED LAMP OR OTHER?

LED LAMP OR OTHER is a medical device that received FDA 510(k) clearance on 2009-12-18. The listed applicant is Intravista Medical Systems, Inc.. The 510(k) number is K092883.

When did LED LAMP OR OTHER receive FDA 510(k) clearance?

LED LAMP OR OTHER received FDA 510(k) clearance on 2009-12-18, under 510(k) number K092883.

Who is the listed applicant for LED LAMP OR OTHER?

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

What is the FDA product code for LED LAMP OR OTHER?

The FDA product code for LED LAMP OR OTHER is HJO.

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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

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

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