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510(k) K913474

RESPIRE DISPOSABLE PULMONARY RESUSCITATOR by Med-Tek Innovations, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1993
Date Received
August 5, 1991
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-Tek Innovations, Inc.

  • K944194 — DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME (September 13, 1994)
  • K905288 — ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES (April 9, 1991)

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