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FDA 510(k)

ULTRASONIC PACHYMETER

K-Number: K921705 · 1992-11-16

ApplicantPrecision Corneal Instruments
Decision Date1992-11-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC PACHYMETER is the device name listed in this FDA 510(k) record. The listed applicant is Precision Corneal Instruments. It received FDA 510(k) clearance on 1992-11-16 under 510(k) number K921705. 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 ULTRASONIC PACHYMETER?

ULTRASONIC PACHYMETER is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Precision Corneal Instruments. The 510(k) number is K921705.

When did ULTRASONIC PACHYMETER receive FDA 510(k) clearance?

ULTRASONIC PACHYMETER received FDA 510(k) clearance on 1992-11-16, under 510(k) number K921705.

Who is the listed applicant for ULTRASONIC PACHYMETER?

The FDA 510(k) record lists Precision Corneal Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC PACHYMETER?

The FDA product code for ULTRASONIC PACHYMETER is IYO.

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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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