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

Name: FDA 510(k) clearance K901643
Creator: U.S. Food and Drug Administration
Published: 1990-07-25

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.. Device class: 1.

Clearance details

Applicant: Healthdyne Cardiovascular, Inc.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1990-04-09
Decision date: 1990-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K914419 — AMNIOTEST(TM)1993-09-01
K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE1992-11-05
K921738 — SONO-VU US(TM), MODIFICATION1992-04-27

More clearances from Healthdyne Cardiovascular, Inc.

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K901382 — ISOFLO(TM) HIGH PRESSURE INJECTION LINES1990-07-19
K901084 — ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.1990-06-01
K900665 — DRESSING CHANGE KIT1990-05-14
K895763 — ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING1989-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.