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510(k) K901382

ISOFLO(TM) HIGH PRESSURE INJECTION LINES by Healthdyne Cardiovascular, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1990
Date Received
March 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Healthdyne Cardiovascular, Inc.

  • K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY (July 25, 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)

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