ISOFLO(TM) AMNIOCENTESIS TRAY— 510(k) K901643

Substantially Equivalent

Healthdyne Cardiovascular, Inc.

FDA 510(k) clearance K901643 for ISOFLO(TM) AMNIOCENTESIS TRAY, Substantially Equivalent on 1990-07-25. Applicant: Healthdyne Cardiovascular, Inc..

Clearance details

Applicant: Healthdyne Cardiovascular, Inc.
Product code: Code HIO
Advisory panel: Obstetrics/Gynecology
Date received: 1990-04-09
Decision date: 1990-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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