Medical Device Manufacturer · SE , Molnlycke, Vastra Gotaland

Breas Medical AB - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2006
15
Total
15
Cleared
0
Denied

FDA 510(k) cleared devices by Breas Medical AB Anesthesiology ✕

15 devices
1-12 of 15
Cleared May 20, 2025
EveryWare
K242485 · MOD
Anesthesiology · 272d
Cleared May 16, 2025
Clearo
K242438 · NHJ
Anesthesiology · 273d
Cleared Jan 13, 2025
Vivo 45 LS
K233452 · NOU
Anesthesiology · 451d
Cleared Dec 13, 2024
Vivo 1, Vivo 2
K240778 · MNS
Anesthesiology · 267d
Cleared Dec 13, 2024
Vivo 3
K240779 · MNT
Anesthesiology · 267d
Cleared Jan 27, 2021
Vivo 45 LS
K193586 · NOU
Anesthesiology · 401d
Cleared Nov 09, 2016
Vivo 60
K160481 · NOU
Anesthesiology · 261d
Cleared May 14, 2009
BREAS VIVO 40 SYSTEM
K090113 · MNT
Anesthesiology · 113d
Cleared Feb 15, 2008
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
K071702 · MNT
Anesthesiology · 239d
Cleared Jan 22, 2007
BREAS ISLEEP 20I
K063476 · BZD
Anesthesiology · 67d
Cleared Aug 18, 2006
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
K060657 · BZD
Anesthesiology · 158d
Cleared Jun 23, 2006
BREAS ISLEEP 20+
K061057 · BZD
Anesthesiology · 67d
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