SIMVAC
FDA 510(k) clearance K811991 · decided 1981-08-12
Clearance details
- K-number
- K811991
- Device name
- SIMVAC
- Applicant
- The Lynn Terrell Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-13
- Decision date
- 1981-08-12
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- CBO
- Device class
- 2
- Regulation number
- 868.5955
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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) | Foregger | 1976-08-04 |
Recalls involving this device
No recalls on record reference this clearance.