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FDA 510(k)

TONOSHIELD TONOMETER SHIELD

K-Number: K923877 · 1992-09-30

ApplicantOasis Medical, Inc.
Decision Date1992-09-30
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TONOSHIELD TONOMETER SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medical, Inc.. It received FDA 510(k) clearance on 1992-09-30 under 510(k) number K923877. 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 TONOSHIELD TONOMETER SHIELD?

TONOSHIELD TONOMETER SHIELD is a medical device that received FDA 510(k) clearance on 1992-09-30. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K923877.

When did TONOSHIELD TONOMETER SHIELD receive FDA 510(k) clearance?

TONOSHIELD TONOMETER SHIELD received FDA 510(k) clearance on 1992-09-30, under 510(k) number K923877.

Who is the listed applicant for TONOSHIELD TONOMETER SHIELD?

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

What is the FDA product code for TONOSHIELD TONOMETER SHIELD?

The FDA product code for TONOSHIELD TONOMETER SHIELD is HKY.

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Other records listing Oasis Medical, Inc. as applicant

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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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