Valve, I.M.V. (U-Mid One Way)
FDA 510(k) K760039 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK760039
Submission
- Device name
- Valve, I.M.V. (U-Mid One Way)
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- June 15, 1976
- Decision date
- July 16, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBO – Attachment, Intermittent Mandatory Ventilation (Imv)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5955
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K811991 | SimvacCBO · Traditional | The Lynn Terrell Co. | 08/12/1981SE |
| K811908 | Imv ManifoldsCBO · Traditional | Airlife, Inc. | 07/16/1981SE |
| K791913 | Imv Manifold #M-506CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791912 | Imv for Monitoring #M-510CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791911 | Fall-Safe Imv #M-511CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791909 | Imv Bushing #M-513CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791906 | Imv W/Bag #M-507CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791905 | Imv W/Bag & Tubing #M-508CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791904 | Imv W/Bag & Hoses #M-509CBO · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K781706 | Respirator/Gill 1/SIMVCBO · Traditional | Chemetron Medical Products, Inc. | 01/22/1979SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Valve, I.M.V. (U-Mid One Way) cleared by the FDA?
Valve, I.M.V. (U-Mid One Way) (K760039) received a 510(k) decision of Substantially Equivalent on July 16, 1976, 31 days after the submission was received.
What is the product code of K760039?
The FDA product code is CBO – Attachment, Intermittent Mandatory Ventilation (Imv), a Class II (moderate risk) device regulated under 21 CFR 868.5955.