Atlas FDA

CBC

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Bottle, Collection And Trap, Breathing System (Uncalibrated)
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
1994: 1 · 1998: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIRD 1000 PV PORTABLE VENTILATOR (K925422)Bird Products Corp.1993-05-13
AMBU SUCTION BOOSTER (K790035)Narco Air-Shields1979-03-23
BOTTLE, CONDENSATE (#1628) (K760082)Inspiron Corp.1976-07-16

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Every clearance here is in the API, with alerts when new ones post.