510(k) K760039
- Device
- Valve, I.m.v. (u-mid One Way)
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K760039
- Product code
- CBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-16
- Date received
- 1976-06-15
- Regulation
- 868.5955
- Classification name
- Attachment, Intermittent Mandatory Ventilation (Imv)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 1924066
- 3011137372
- 3004365956
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CBO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811991 | SIMVAC | The Lynn Terrell Co. | 1981-08-12 |
| K811908 | IMV MANIFOLDS | Airlife, Inc. | 1981-07-16 |
| K791904 | IMV W/BAG & HOSES #M-509 | Mem Medical, Inc. | 1979-10-09 |
| K791905 | IMV W/BAG & TUBING #M-508 | Mem Medical, Inc. | 1979-10-09 |
| K791906 | IMV W/BAG #M-507 | Mem Medical, Inc. | 1979-10-09 |
| K791909 | IMV BUSHING #M-513 | Mem Medical, Inc. | 1979-10-09 |
| K791911 | FALL-SAFE IMV #M-511 | Mem Medical, Inc. | 1979-10-09 |
| K791912 | IMV FOR MONITORING #M-510 | Mem Medical, Inc. | 1979-10-09 |
| K791913 | IMV MANIFOLD #M-506 | Mem Medical, Inc. | 1979-10-09 |
| K781706 | RESPIRATOR/GILL 1/SIMV | Chemetron Medical Products, Inc. | 1979-01-22 |
| K760891 | INSPIRON I.M.V. SET UP | Inspiron Corp. | 1976-12-09 |
| K760680 | INTERMITTENT MANDATORY VENTILATION | B & F Medical Products, Inc. | 1976-09-27 |
| K760263 | I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) | Foregger | 1976-08-04 |
| K760221 | I.P.P.B., DIS. W/MANIFOLD/NEBULIZER | Manner Medical Products | 1976-08-03 |