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FDA 510(k)

AL-2000 COMBINED BIOMETER AND PACHYMETER

K-Number: K012803 · 2002-04-08

ApplicantTomey Corp.
Decision Date2002-04-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AL-2000 COMBINED BIOMETER AND PACHYMETER is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corp.. It received FDA 510(k) clearance on 2002-04-08 under 510(k) number K012803. 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 AL-2000 COMBINED BIOMETER AND PACHYMETER?

AL-2000 COMBINED BIOMETER AND PACHYMETER is a medical device that received FDA 510(k) clearance on 2002-04-08. The listed applicant is Tomey Corp.. The 510(k) number is K012803.

When did AL-2000 COMBINED BIOMETER AND PACHYMETER receive FDA 510(k) clearance?

AL-2000 COMBINED BIOMETER AND PACHYMETER received FDA 510(k) clearance on 2002-04-08, under 510(k) number K012803.

Who is the listed applicant for AL-2000 COMBINED BIOMETER AND PACHYMETER?

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

What is the FDA product code for AL-2000 COMBINED BIOMETER AND PACHYMETER?

The FDA product code for AL-2000 COMBINED BIOMETER AND PACHYMETER is IYO.

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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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