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FDA 510(k)

SURGICAL IOP MONITOR

K-Number: K832996 · 1983-11-28

ApplicantMiami Eye Technology, Inc.
Decision Date1983-11-28
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGICAL IOP MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Miami Eye Technology, Inc.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K832996. 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 SURGICAL IOP MONITOR?

SURGICAL IOP MONITOR is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Miami Eye Technology, Inc.. The 510(k) number is K832996.

When did SURGICAL IOP MONITOR receive FDA 510(k) clearance?

SURGICAL IOP MONITOR received FDA 510(k) clearance on 1983-11-28, under 510(k) number K832996.

Who is the listed applicant for SURGICAL IOP MONITOR?

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

What is the FDA product code for SURGICAL IOP MONITOR?

The FDA product code for SURGICAL IOP MONITOR is HKY.

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Other records listing Miami Eye Technology, 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.

K841101CLAYMAN-PAREL CAPSULE COUPEURK832912GELENDER VACUUM FIXATION RING SYSK832997EPA AUTOMATED INFUSION POLEK832911ABBOTT GLOBE HOLDERK831702RARE-EARTH INTRA-OCULAR MAGNET

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

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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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