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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K921377
Device Name P/METER
Applicant
Zertl Medical, Inc.
7 Knox Ct.
Lawrenceville,  NJ  08648
Applicant Contact GLENN LAUB
Correspondent
Zertl Medical, Inc.
7 Knox Ct.
Lawrenceville,  NJ  08648
Correspondent Contact GLENN LAUB
Regulation Number870.2100
Classification Product Code
DPW  
Date Received03/24/1992
Decision Date 10/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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