Product code CBO— Anesthesiology
FALL-SAFE IMV #M-511
- Classification name
- Attachment, Intermittent Mandatory Ventilation (Imv)
- Device class
- Class 2
- Regulation
- 21 CFR 868.5955
- Advisory panel
- Anesthesiology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code CBO
FDA has cleared devices under product code CBO between 1976 and 1981, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1981
- 1979
- 1976
Top applicants under product code CBO
Recent clearances under product code CBO
- K811991 — SIMVAC
- K811908 — IMV MANIFOLDS
- K791904 — IMV W/BAG & HOSES #M-509
- K791905 — IMV W/BAG & TUBING #M-508
- K791906 — IMV W/BAG #M-507
- K791909 — IMV BUSHING #M-513
- K791911 — FALL-SAFE IMV #M-511
- K791912 — IMV FOR MONITORING #M-510
- K791913 — IMV MANIFOLD #M-506
- K781706 — RESPIRATOR/GILL 1/SIMV
- K760891 — INSPIRON I.M.V. SET UP
- K760680 — INTERMITTENT MANDATORY VENTILATION
- K760263 — I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT)
- K760221 — I.P.P.B., DIS. W/MANIFOLD/NEBULIZER
- K760039 — VALVE, I.M.V. (U-MID ONE WAY)
Data sourced from openFDA. This site is unofficial and independent of the FDA.