Atlas FDA

BXO

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Transducer, Gas Pressure
Device class
Class I (low risk)
Regulation
21 CFR 868.2900
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1992: 1 · 1993: 1 · 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AG-839PA CO2 MODULE AND ACCESSORIES (K944027)Nihon Kohden America, Inc.1994-08-31
POLY G PHYSIOLOGICAL DATA RECORDER (K897107)Cns, Inc.1990-03-12

Track BXO automatically

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