Y2000 POCKET RESCUE— 510(k) K010191

Name: FDA 510(k) clearance K010191
Creator: U.S. Food and Drug Administration
Published: 2001-03-14

Substantially Equivalent

Cheen Houng Ent. Co. , Ltd.

FDA 510(k) clearance K010191 for Y2000 POCKET RESCUE, Substantially Equivalent on 2001-03-14. Applicant: Cheen Houng Ent. Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Cheen Houng Ent. Co. , Ltd.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2001-01-22
Decision date: 2001-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei (Shulin), TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBP

view all

K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)2024-10-29
K234053 — F&P Optiflow Flow Diverter2024-08-09
K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb)2021-12-23
K192285 — CPR Face Shield2020-11-25
K173770 — OJR215 Pressure Relief Manifold2019-04-05

More clearances from Cheen Houng Ent. Co. , Ltd.

view all

K121587 — BREATH SHAKE2013-11-22
K021390 — PMX COMPACT RESUCITATOR2002-10-04
K003927 — Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH022001-06-26
K981415 — 0-20 CM H20 PEEP VALVE1998-07-14
K970688 — POCKET RESCUE1997-09-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.