CBO · Attachment, Intermittent Mandatory Ventilation (Imv)
Anesthesiology · 21 CFR 868.5955 · Class 2
Overview
| Product Code | CBO |
|---|---|
| Device Name | Attachment, Intermittent Mandatory Ventilation (Imv) |
| Regulation | 21 CFR 868.5955 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K811991 | SIMVAC | The Lynn Terrell Co. | Aug 12, 1981 | SESE |
| K811908 | IMV MANIFOLDS | Airlife, Inc. | Jul 16, 1981 | SESE |
| K791913 | IMV MANIFOLD #M-506 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791912 | IMV FOR MONITORING #M-510 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791911 | FALL-SAFE IMV #M-511 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791909 | IMV BUSHING #M-513 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791906 | IMV W/BAG #M-507 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791905 | IMV W/BAG & TUBING #M-508 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791904 | IMV W/BAG & HOSES #M-509 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K781706 | RESPIRATOR/GILL 1/SIMV | Chemetron Medical Products, Inc. | Jan 22, 1979 | SESE |
| K760891 | INSPIRON I.M.V. SET UP | Inspiron Corp. | Dec 9, 1976 | SESE |
| K760680 | INTERMITTENT MANDATORY VENTILATION | B & F Medical Products, Inc. | Sep 27, 1976 | SESE |
| K760263 | I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) | Foregger | Aug 4, 1976 | SESE |
| K760221 | I.P.P.B., DIS. W/MANIFOLD/NEBULIZER | Manner Medical Products | Aug 3, 1976 | SESE |
| K760039 | VALVE, I.M.V. (U-MID ONE WAY) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 16, 1976 | SESE |
Top Applicants
- Mem Medical, Inc. — 7 clearances
- Airlife, Inc. — 1 clearance
- B & F Medical Products, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Chemetron Medical Products, Inc. — 1 clearance
