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510(k) K812022

ZEE MANUAL RESUSCITATOR by Zee Medical Products Co., Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
July 20, 1981
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 Zee Medical Products Co., Inc.

  • K823501 — ZEE SPHYGMOMANOMETER (January 21, 1983)
  • K813156 — ULTRA-WIDE SAFETY SPECTACLE FRAME (December 14, 1981)
  • K813016 — ZEE TRACTION SPLINT (November 24, 1981)
  • K812814 — ZEE SURGICAL INSTRUMENTS (November 6, 1981)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)
  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K812284 — ZEE ELECTRODE-GEL (September 8, 1981)

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  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
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  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
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