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FDA 510(k), K073155, VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
FDA 510(k), K073155, VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
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510(K) Number: K073155
Device Name: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
Manufacturer: TOM J HEALY
Device Classification Name: Spirometer, Diagnostic
Regulation Number: BZG
Classification Product Code: KXA
Date Received: 11/08/2007
Decision Date: 06/04/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
Manufacturer: TOM J HEALY
Device Classification Name: Spirometer, Diagnostic
Regulation Number: BZG
Classification Product Code: KXA
Date Received: 11/08/2007
Decision Date: 06/04/2008
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
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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