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510(k) K242438

Clearo by Breas Medical AB — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
August 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Breas Medical AB

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  • K233452 — Vivo 45 LS (January 13, 2025)
  • K240778 — Vivo 1, Vivo 2 (December 13, 2024)
  • K240779 — Vivo 3 (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)
  • K060657 — ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (August 18, 2006)

Other clearances for product code NHJ

  • K231728 — BiWaze Clear System (April 8, 2024)
  • K213564 — BiWaze Clear System (December 21, 2022)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 2020)
  • K192143 — Maximus System (February 14, 2020)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K132988 — VITAL COUGH (March 28, 2014)
  • K124032 — METANEB (April 25, 2013)