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510(k) K901643

ISOFLO(TM) AMNIOCENTESIS TRAY by Healthdyne Cardiovascular, Inc. — Product Code HIO

K901643 is an FDA 510(k) premarket notification submitted by Healthdyne Cardiovascular, Inc. for the device "ISOFLO(TM) AMNIOCENTESIS TRAY". The FDA issued a decision of Substantially Equivalent on July 25, 1990. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. Healthdyne Cardiovascular, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1990
Date Received
April 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Device Class
Class I
Regulation Number
884.1550
Review Panel
OB
Submission Type

Other clearances by Healthdyne Cardiovascular, Inc.

  • K901382 — ISOFLO(TM) HIGH PRESSURE INJECTION LINES (July 19, 1990)
  • K901084 — ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. (June 1, 1990)
  • K900665 — DRESSING CHANGE KIT (May 14, 1990)
  • K895763 — ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING (December 22, 1989)

Other clearances for product code HIO

  • K960203 — G.E. STERILE AMNIOCENTESIS TRAY (March 14, 1996)
  • K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (March 12, 1996)
  • K914419 — AMNIOTEST(TM) (September 1, 1993)
  • K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (November 5, 1992)
  • K921738 — SONO-VU US(TM), MODIFICATION (April 27, 1992)
  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K904583 — SONO-VU US(TM) (June 24, 1991)
  • K900021 — PERCU-SET(TM) (March 29, 1990)
  • K896031 — AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (January 12, 1990)
  • K894031 — PHARMASEAL GENETIC AMNIOCENTESIS TRAY (August 4, 1989)

FDA data resources