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510(k) K882278

RESUSCITATION BAG CONTROLLER (RBC) by Physician Engineered Products, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1988
Date Received
June 1, 1988
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 Physician Engineered Products, Inc.

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  • K974830 — ULTRA BILI LIGHT (May 20, 1998)
  • K883818 — MODIFIED REFLUX REDUCER (November 21, 1988)
  • K882291 — RETROFIT BABY FACE SHIELD (RFS) (June 20, 1988)
  • K873700 — INSTITUTIONAL BILI LIGHT (IBL) (December 11, 1987)
  • K850599 — HOME BILI LIGHTS-MODEL 100 (June 17, 1985)

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