Attachment, Intermittent Mandatory Ventilation (Imv)
The Intermittent Mandatory Ventilation (IMV) Attachment is an anesthesiology device that connects to an existing ventilator or breathing circuit to provide intermittent mandatory breaths at set intervals while allowing the patient to breathe spontaneously between machine-delivered breaths, used in weaning patients from full ventilatory support. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBO, regulated under 21 CFR 868.5955, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting.
Basic Information
- Product Code
- CBO
- Device Class
- FDA class 2
- Regulation Number
- 868.5955
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K811991 | SIMVAC | Aug 12, 1981 | Substantially Equivalent | The Lynn Terrell Co. |
| K811908 | IMV MANIFOLDS | Jul 16, 1981 | Substantially Equivalent | Airlife, Inc. |
| K791913 | IMV MANIFOLD #M-506 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791912 | IMV FOR MONITORING #M-510 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791911 | FALL-SAFE IMV #M-511 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791909 | IMV BUSHING #M-513 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791906 | IMV W/BAG #M-507 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791905 | IMV W/BAG & TUBING #M-508 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791904 | IMV W/BAG & HOSES #M-509 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K781706 | RESPIRATOR/GILL 1/SIMV | Jan 22, 1979 | Substantially Equivalent | Chemetron Medical Products, Inc. |
| K760891 | INSPIRON I.M.V. SET UP | Dec 09, 1976 | Substantially Equivalent | Inspiron Corp. |
| K760680 | INTERMITTENT MANDATORY VENTILATION | Sep 27, 1976 | Substantially Equivalent | B & F Medical Products, Inc. |
| K760263 | I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) | Aug 04, 1976 | Substantially Equivalent | Foregger |
| K760221 | I.P.P.B., DIS. W/MANIFOLD/NEBULIZER | Aug 03, 1976 | Substantially Equivalent | Manner Medical Products |
| K760039 | VALVE, I.M.V. (U-MID ONE WAY) | Jul 16, 1976 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.