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FDA 510(k), K943106, ADULT VENTILATOR
FDA 510(k), K943106, ADULT VENTILATOR
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510(K) Number: K943106
Device Name: ADULT VENTILATOR
Manufacturer: JIM HITCHIN
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 06/29/1994
Decision Date: 12/28/1995
Decision Date: SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty: Anesthesiology
Device Name: ADULT VENTILATOR
Manufacturer: JIM HITCHIN
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 06/29/1994
Decision Date: 12/28/1995
Decision Date: SE SUBJECT TO TRACKING REG (ST)
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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