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FDA 510(k)

TONOMETER, DIGITON

K-Number: K781105 · 1978-09-27

ApplicantIcal, Inc.
Decision Date1978-09-27
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TONOMETER, DIGITON is the device name listed in this FDA 510(k) record. The listed applicant is Ical, Inc.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781105. 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 TONOMETER, DIGITON?

TONOMETER, DIGITON is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Ical, Inc.. The 510(k) number is K781105.

When did TONOMETER, DIGITON receive FDA 510(k) clearance?

TONOMETER, DIGITON received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781105.

Who is the listed applicant for TONOMETER, DIGITON?

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

What is the FDA product code for TONOMETER, DIGITON?

The FDA product code for TONOMETER, DIGITON 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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