FDA 510(k) Application Details - K002686

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K002686
Device Name Ventilator, Continuous, Facility Use
Applicant NELLCOR PURITAN BENNETT, INC.
2800 NORTHWEST BLVD.
MINNEAPOLIS, MN 55441 US
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Contact CHERYL NORTON
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 08/28/2000
Decision Date 10/18/2000
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Special
Reviewed By Third Party N
Expedited Review



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