FDA 510(k), K113053, BIPAP A 30 VENTILATORY SUPPORT SYSTEM
FDA 510(k), K113053, BIPAP A 30 VENTILATORY SUPPORT SYSTEM
510(K) Number: K113053
Device Name: BIPAP A 30 VENTILATORY SUPPORT SYSTEM
Manufacturer: ELAINE LARKIN
Device Classification Name: Ventilator, Continuous, Non-Life-Supporting
Regulation Number: MNS
Classification Product Code: KXA
Date Received: 10/13/2011
Decision Date: 02/01/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
462 pages (2,463 of 2,925 original pages are fully redacted)
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