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510(k) K003927

Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 by Cheen Houng Ent. Co. , Ltd. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2001
Date Received
December 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
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)
  • K010191 — Y2000 POCKET RESCUE (March 14, 2001)
  • K981415 — 0-20 CM H20 PEEP VALVE (July 14, 1998)
  • K970688 — POCKET RESCUE (September 26, 1997)

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