Chrysalis Intelligence · Product Codes · CBP

CBP · Valve, Non-Rebreathing

Anesthesiology · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 868.5870
Total clearances
4
2020-11-25 → 2024-10-29
Last 12 months
0
Unique sponsors
4
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.5870
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Meditera Tibbi Malzeme San VE Tic AS 1 0 2021-12-23
Fisher & Paykel Healthcare, Ltd. 1 0 2024-08-09
Dehas Medical Systems GmbH 1 0 2024-10-29
Firstar Healthcare Company Limited (Guangzhou) 1 0 2020-11-25
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-10-29 K241366 Dehas Medical Systems GmbH QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
2024-08-09 K234053 Fisher & Paykel Healthcare, Ltd. F&P Optiflow Flow Diverter
2021-12-23 K210992 Meditera Tibbi Malzeme San VE Tic AS Altech® Exhalation Valve (Single Limb and Dual Limb)
2020-11-25 K192285 Firstar Healthcare Company Limited (Guangzhou) CPR Face Shield