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510(k) K060657

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. by Breas Medical AB — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2006
Date Received
March 13, 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

Other clearances by Breas Medical AB

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  • K240778 — Vivo 1, Vivo 2 (December 13, 2024)
  • K193586 — Vivo 45 LS (January 27, 2021)
  • K160481 — Vivo 60 (November 9, 2016)
  • K090113 — BREAS VIVO 40 SYSTEM (May 14, 2009)
  • K071702 — BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 (February 15, 2008)
  • K063476 — BREAS ISLEEP 20I (January 22, 2007)

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