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FDA 510(k)

PROVIEW EYE PRESSURE MONITOR

K-Number: K011199 · 2001-07-02

ApplicantBausch & Lomb, Inc.
Decision Date2001-07-02
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PROVIEW EYE PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2001-07-02 under 510(k) number K011199. 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 PROVIEW EYE PRESSURE MONITOR?

PROVIEW EYE PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2001-07-02. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K011199.

When did PROVIEW EYE PRESSURE MONITOR receive FDA 510(k) clearance?

PROVIEW EYE PRESSURE MONITOR received FDA 510(k) clearance on 2001-07-02, under 510(k) number K011199.

Who is the listed applicant for PROVIEW EYE PRESSURE MONITOR?

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

What is the FDA product code for PROVIEW EYE PRESSURE MONITOR?

The FDA product code for PROVIEW EYE PRESSURE MONITOR is HKY.

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Other records listing Bausch & Lomb, 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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