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510(k) K923660

MEDISONIC OXYGEN FLOW CONTROLLER by Medisonic U.S.A., Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1993
Date Received
July 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Medisonic U.S.A., Inc.

  • K924577 — MEDIVAC (March 23, 1993)
  • K901114 — MEDISONIC HUMDIFIER/INHALER (May 22, 1990)
  • K896192 — MEDISONIC PNEU-NEB (January 3, 1990)
  • K894961 — MEDISONIC ULTRA-SONIC INHALER (November 24, 1989)

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