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510(k) K010191

Y2000 POCKET RESCUE by Cheen Houng Ent. Co. , Ltd. — Product Code CBP

K010191 is an FDA 510(k) premarket notification submitted by Cheen Houng Ent. Co. , Ltd. for the device "Y2000 POCKET RESCUE". The FDA issued a decision of Substantially Equivalent on March 14, 2001. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Cheen Houng Ent. Co. , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2001
Date Received
January 22, 2001
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 Cheen Houng Ent. Co. , Ltd.

  • K121587 — BREATH SHAKE (November 22, 2013)
  • K021390 — PMX COMPACT RESUCITATOR (October 4, 2002)
  • K003927 — Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 (June 26, 2001)
  • K981415 — 0-20 CM H20 PEEP VALVE (July 14, 1998)
  • K970688 — POCKET RESCUE (September 26, 1997)

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