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FDA 510(k)

P/METER

K-Number: K921377 · 1993-10-12

ApplicantZertl Medical, Inc.
Decision Date1993-10-12
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

P/METER is the device name listed in this FDA 510(k) record. The listed applicant is Zertl Medical, Inc.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K921377. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P/METER?

P/METER is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Zertl Medical, Inc.. The 510(k) number is K921377.

When did P/METER receive FDA 510(k) clearance?

P/METER received FDA 510(k) clearance on 1993-10-12, under 510(k) number K921377.

Who is the listed applicant for P/METER?

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

What is the FDA product code for P/METER?

The FDA product code for P/METER is DPW.

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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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