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FDA 510(k), K954140, MASTERSCREEN IOS
FDA 510(k), K954140, MASTERSCREEN IOS
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510(K) Number: K954140
Device Name: MASTERSCREEN IOS
Manufacturer: DETLEF GROTHEER
Device Classification Name: Spirometer, Diagnostic
Regulation Number: BZG
Classification Product Code: KXA
Date Received: 09/01/1995
Decision Date: 12/14/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: MASTERSCREEN IOS
Manufacturer: DETLEF GROTHEER
Device Classification Name: Spirometer, Diagnostic
Regulation Number: BZG
Classification Product Code: KXA
Date Received: 09/01/1995
Decision Date: 12/14/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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