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510(k) K934821

CPROTECTOR by Certified Safety Mfg., Inc. — Product Code CBP

K934821 is an FDA 510(k) premarket notification submitted by Certified Safety Mfg., Inc. for the device "CPROTECTOR". The FDA issued a decision of Substantially Equivalent on January 6, 1994. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Certified Safety Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1994
Date Received
October 8, 1993
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 Certified Safety Mfg., Inc.

  • K960587 — CPROTECTOR 2000 (July 21, 1997)
  • K960615 — GAUZE COMPRESS (November 25, 1996)
  • K960624 — CERTI COOL INSTANT COLD COMPRESS (May 6, 1996)
  • K953102 — BLOODBORNE PATHOGEN KIT (December 11, 1995)
  • K946338 — CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING (March 29, 1995)
  • K945002 — 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE (March 22, 1995)
  • K945004 — 2, 3 & 4 BANDADGE COMPRESS (March 22, 1995)
  • K940249 — CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING (October 3, 1994)
  • K941311 — FIRST AID/TRUMA KIT (June 14, 1994)
  • K940358 — X-LARGE MULTI-FUNCTION TRAUMA DRESSING (March 23, 1994)

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