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FDA 510(k)

KREMER CORNEOMETER ULTRASONIC PACHOMETER

K-Number: K810660 · 1981-08-21

ApplicantAccutome, Inc.
Decision Date1981-08-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KREMER CORNEOMETER ULTRASONIC PACHOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Accutome, Inc.. It received FDA 510(k) clearance on 1981-08-21 under 510(k) number K810660. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KREMER CORNEOMETER ULTRASONIC PACHOMETER?

KREMER CORNEOMETER ULTRASONIC PACHOMETER is a medical device that received FDA 510(k) clearance on 1981-08-21. The listed applicant is Accutome, Inc.. The 510(k) number is K810660.

When did KREMER CORNEOMETER ULTRASONIC PACHOMETER receive FDA 510(k) clearance?

KREMER CORNEOMETER ULTRASONIC PACHOMETER received FDA 510(k) clearance on 1981-08-21, under 510(k) number K810660.

Who is the listed applicant for KREMER CORNEOMETER ULTRASONIC PACHOMETER?

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

What is the FDA product code for KREMER CORNEOMETER ULTRASONIC PACHOMETER?

The FDA product code for KREMER CORNEOMETER ULTRASONIC PACHOMETER is IYO.

Related Clinical Trials

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.

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Other records listing Accutome, 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.

K123349A-SCAN PLUS CONNECTK103471UBM PLUSK050552PACHPEN PACHYMETER, MODEL 24-5100K032956ACCUSONIC A-SCAN MODEL, 24-4000K820050KREMER BLADE GAUGE

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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