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510(k) K943386

CPR MICROMASK by Plasco, Inc. — Product Code CBP

K943386 is an FDA 510(k) premarket notification submitted by Plasco, Inc. for the device "CPR MICROMASK". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Plasco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
July 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Plasco, Inc.

  • K980066 — CPR FILTERSHIELD (July 16, 1998)
  • K953414 — CPR MICROMASK WITH OXYGEN INLET (March 20, 1996)
  • K951483 — CPR MICROMASK (October 19, 1995)
  • K950769 — CPR MICROMASK PLUS CATALOG NO 73-402 (March 10, 1995)
  • K950770 — CPR MICROSHIELD II (March 10, 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)

Other clearances for product code CBP

  • K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT (October 29, 2024)
  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb) (December 23, 2021)
  • K192285 — CPR Face Shield (November 25, 2020)
  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (July 9, 2015)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)

FDA data resources