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510(k) K950392

4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 by Cal West Trading Co. — Product Code CBP

K950392 is an FDA 510(k) premarket notification submitted by Cal West Trading Co. for the device "4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050". 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. Cal West Trading Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
February 1, 1995
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 Cal West Trading Co.

  • K933756 — MAGNASHIELD CPR MOUTH BARRIER (January 5, 1994)
  • K920269 — EZ GAUZE SPONGE (April 22, 1992)
  • K914842 — GAUZE BANDAGE ROLL (December 4, 1991)
  • K912950 — COMPRESS DRESSING (October 4, 1991)
  • K912952 — BANDAGE COMPRESS (October 4, 1991)
  • K912953 — GAUZE COMPRESS (September 30, 1991)
  • K912954 — STRETCH GAUZE BANDAGE (September 10, 1991)
  • K912951 — 12-PLY GAUZE PAD (September 10, 1991)
  • K912955 — EYE PAD (September 10, 1991)
  • K912949 — TRIANGULAR BANDAGE,40 (September 6, 1991)

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