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FDA 510(k)

OCULAB TONOPEN

K-Number: K852774 · 1985-08-20

ApplicantOculab, Inc.
Decision Date1985-08-20
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULAB TONOPEN is the device name listed in this FDA 510(k) record. The listed applicant is Oculab, Inc.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K852774. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAB TONOPEN?

OCULAB TONOPEN is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Oculab, Inc.. The 510(k) number is K852774.

When did OCULAB TONOPEN receive FDA 510(k) clearance?

OCULAB TONOPEN received FDA 510(k) clearance on 1985-08-20, under 510(k) number K852774.

Who is the listed applicant for OCULAB TONOPEN?

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

What is the FDA product code for OCULAB TONOPEN?

The FDA product code for OCULAB TONOPEN is HKY.

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Other records listing Oculab, 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.

K884619PACH-PEN CALCULATORK882750OCU-FILM TIP COVERK862016PACH-PEN SURGICAL DRAPEK860205BIO-PEN CALCULATORK860061OCULAB BIOMETRICPENK860062OCULAB PACHPEN

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Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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