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FDA 510(k), K951901, MASTERSCREEN PFT BODY
FDA 510(k), K951901, MASTERSCREEN PFT BODY
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510(K) Number: K951901
Device Name: MASTERSCREEN PFT BODY
Manufacturer: DETLEF GROTHEER
Device Classification Name: Plethysmograph, Volume
Regulation Number: JEH
Classification Product Code: KXA
Date Received: 04/24/1995
Decision Date: 07/31/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: MASTERSCREEN PFT BODY
Manufacturer: DETLEF GROTHEER
Device Classification Name: Plethysmograph, Volume
Regulation Number: JEH
Classification Product Code: KXA
Date Received: 04/24/1995
Decision Date: 07/31/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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