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510(k) K010191

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

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)

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