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510(k) K980066

CPR FILTERSHIELD by Plasco, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1998
Date Received
January 7, 1998
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 Plasco, Inc.

  • K953414 — CPR MICROMASK WITH OXYGEN INLET (March 20, 1996)
  • K951483 — CPR MICROMASK (October 19, 1995)
  • K950770 — CPR MICROSHIELD II (March 10, 1995)
  • K950769 — CPR MICROMASK PLUS CATALOG NO 73-402 (March 10, 1995)
  • K943386 — CPR MICROMASK (February 21, 1995)
  • K932649 — PHARMAFEED (November 16, 1993)
  • K880337 — MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (April 14, 1988)
  • K870623 — ENTERAL ADMINISTRATION SET (June 26, 1987)
  • K870796 — MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY (April 1, 1987)
  • K870019 — THE LAHR BALLOON (April 1, 1987)

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  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)