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FDA 510(k)

OCULAR CEREBRAL VASCULAR MONITOR

K-Number: K772130 · 1977-11-28

ApplicantDigilab, Inc.
Decision Date1977-11-28
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULAR CEREBRAL VASCULAR MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Digilab, Inc.. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772130. 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 OCULAR CEREBRAL VASCULAR MONITOR?

OCULAR CEREBRAL VASCULAR MONITOR is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Digilab, Inc.. The 510(k) number is K772130.

When did OCULAR CEREBRAL VASCULAR MONITOR receive FDA 510(k) clearance?

OCULAR CEREBRAL VASCULAR MONITOR received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772130.

Who is the listed applicant for OCULAR CEREBRAL VASCULAR MONITOR?

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

What is the FDA product code for OCULAR CEREBRAL VASCULAR MONITOR?

The FDA product code for OCULAR CEREBRAL VASCULAR MONITOR is HKY.

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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

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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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