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510(k) K131877

SAVE II, SAVE II BASIC by Automedx, Inc. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2014
Date Received
June 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Automedx, Inc.

  • K071221 — SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 (September 6, 2007)

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