Atlas FDA

CBO

15 FDA 510(k) clearances · Product code

14 daysmedian time to decision
44 days90th percentile
15clearances measured

FDA profile

Official device name
Attachment, Intermittent Mandatory Ventilation (Imv)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5955
Medical specialty
Anesthesiology
Flags
Life-sustaining
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RecordFirmDate
SIMVAC (K811991)The Lynn Terrell Co.1981-08-12
IMV MANIFOLDS (K811908)Airlife, Inc.1981-07-16
IMV BUSHING #M-513 (K791909)Mem Medical, Inc.1979-10-09
IMV FOR MONITORING #M-510 (K791912)Mem Medical, Inc.1979-10-09
IMV W/BAG & TUBING #M-508 (K791905)Mem Medical, Inc.1979-10-09
FALL-SAFE IMV #M-511 (K791911)Mem Medical, Inc.1979-10-09
IMV W/BAG #M-507 (K791906)Mem Medical, Inc.1979-10-09
IMV MANIFOLD #M-506 (K791913)Mem Medical, Inc.1979-10-09
IMV W/BAG & HOSES #M-509 (K791904)Mem Medical, Inc.1979-10-09
RESPIRATOR/GILL 1/SIMV (K781706)Chemetron Medical Products, Inc.1979-01-22
INSPIRON I.M.V. SET UP (K760891)Inspiron Corp.1976-12-09
INTERMITTENT MANDATORY VENTILATION (K760680)B & F Medical Products, Inc.1976-09-27
I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) (K760263)Foregger1976-08-04
I.P.P.B., DIS. W/MANIFOLD/NEBULIZER (K760221)Manner Medical Products1976-08-03
VALVE, I.M.V. (U-MID ONE WAY) (K760039)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-07-16

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