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510(k) K900577

1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT) by Intertech Resources, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1990
Date Received
February 7, 1990
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 Intertech Resources, Inc.

  • K961318 — 1ST RESPONSE DISPOSABLE MANOMETER (December 17, 1996)
  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (June 8, 1995)
  • K952062 — PFT FILTER (June 8, 1995)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K935036 — HEPA FILTERED HEAT AND MOISTURE EXCHANGER (January 25, 1994)
  • K930816 — HEPA FILTERED HME (July 1, 1993)
  • K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (October 30, 1992)

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