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510(k) K820370

NASAL OXYGEN CATHETER by American Pharmaseal Div. Ahsc — Product Code BZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
February 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5350
Review Panel
AN
Submission Type

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  • K871429 — ANTIMICROBIAL FOLEY CATHETER (August 10, 1987)
  • K871770 — AMERICAN PHARMASEAL WOUND DRESSING (June 26, 1987)
  • K870387 — EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE (May 8, 1987)
  • K870977 — PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE (April 1, 1987)

Other clearances for product code BZB

  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K833351 — DEMAND OXYGEN CONTROLLER (March 19, 1984)
  • K830984 — OXYGEN CATHETERS (May 18, 1983)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K791273 — CONPHAR OXYGEN CATHETER-STERILE (July 24, 1979)
  • K790057 — CATHETER, OXYGEN (February 5, 1979)