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510(k) K844420

MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR by Med-Life, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
November 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Med-Life, Inc.

  • K821306 — HEAD-UP SUPINE SAFETY SUPPORT CUSHION (June 7, 1982)
  • K821307 — ANESTHECACHE (May 14, 1982)

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