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510(k) K063476

BREAS ISLEEP 20I by Breas Medical AB — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2007
Date Received
November 16, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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  • K090113 — BREAS VIVO 40 SYSTEM (May 14, 2009)
  • K071702 — BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 (February 15, 2008)
  • K060657 — ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (August 18, 2006)

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