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510(k) K771299

EMERGENCY OXYGEN RESUSCITATOR by Fraser Sweatman, Inc. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
July 14, 1977
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 Fraser Sweatman, Inc.

  • K770911 — MEDISHIELD JORDON LIFTING FRAME (June 27, 1977)
  • K770910 — MEDISHIELD CERVICAL COLLAR (May 25, 1977)
  • K761140 — FRASER SWEATMAN'S DOUBLE MASK (December 9, 1976)
  • K760766 — PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER (October 8, 1976)
  • K760076 — ABSORBER, ANESTHESIA CIRCLE SYS, CO2 (July 16, 1976)

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  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
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  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)