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FDA 510(k)

OTI MODEL 78-60

K-Number: K951184 · 1995-05-12

ApplicantOti Medical, LLC
Decision Date1995-05-12
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OTI MODEL 78-60 is the device name listed in this FDA 510(k) record. The listed applicant is Oti Medical, LLC. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K951184. 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 OTI MODEL 78-60?

OTI MODEL 78-60 is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Oti Medical, LLC. The 510(k) number is K951184.

When did OTI MODEL 78-60 receive FDA 510(k) clearance?

OTI MODEL 78-60 received FDA 510(k) clearance on 1995-05-12, under 510(k) number K951184.

Who is the listed applicant for OTI MODEL 78-60?

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

What is the FDA product code for OTI MODEL 78-60?

The FDA product code for OTI MODEL 78-60 is HJO.

Related Clinical Trials

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.

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Other records listing Oti Medical, LLC 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.

K951437OTI MODEL TLS-60

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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