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510(k) K833351

DEMAND OXYGEN CONTROLLER by Healthdyne, Inc. — Product Code BZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
September 28, 1983
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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Other clearances for product code BZB

  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K830984 — OXYGEN CATHETERS (May 18, 1983)
  • K820370 — NASAL OXYGEN CATHETER (April 16, 1982)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K791273 — CONPHAR OXYGEN CATHETER-STERILE (July 24, 1979)
  • K790057 — CATHETER, OXYGEN (February 5, 1979)