P/Meter

FDA 510(k) K921377 · Zertl Medical, Inc.

Substantially Equivalent

510(k) numberK921377

Submission

Device name
P/Meter
Applicant
Zertl Medical, Inc.
Lawrenceville, NJ, US
Received
March 24, 1992
Decision date
October 12, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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K222242FloPatch FP120DPW · Traditional Flosonics Medical12/09/2022SE
K213974GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special Synovis Micro Companies Alliance, Inc.04/20/2022SE
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Questions and answers

When was P/Meter cleared by the FDA?

P/Meter (K921377) received a 510(k) decision of Substantially Equivalent on October 12, 1993, 567 days after the submission was received.

What is the product code of K921377?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.