FDA 510(k), K974868, SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER

FDA 510(k), K974868, SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER

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510(K) Number: K974868
Device Name: SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
Manufacturer: PERRY BAROMEDICAL CORP.
Device Classification Name: Chamber, Hyperbaric
Regulation Number: 868.5470
Classification Product Code: CBF
Date Received: 12/29/1997
Decision Date: 07/02/1998
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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