Intermittent Mandatory Ventilation
FDA 510(k) K760680 · B & F Medical Products, Inc.
510(k) numberK760680
Submission
- Device name
- Intermittent Mandatory Ventilation
- Applicant
- B & F Medical Products, Inc.
Mchenry, IL, US - Received
- September 20, 1976
- Decision date
- September 27, 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 |
More from Chemetron Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942645 | B&F Medical Oxygen Reg Mecical Oxy Compress Gas RegBXH · Traditional | 07/27/1994SE |
| K920573 | Cannula Nasal OxygenCAT · Traditional | 08/11/1992SE |
| K913501 | Tracheostomy MaskBYG · Traditional | 01/13/1992SE |
| K861325 | Maxi-Use O2 DeviceNFB · Traditional | 09/09/1986SE |
| K861054 | Disposable Rescue Breathing DeviceCAE · Traditional | 04/09/1986SE |
| K853004 | Portable Oxygen UnitCAW · Traditional | 08/29/1985SE |
| K843691 | Portable Oxygen UnitCAW · Traditional | 11/07/1984SE |
| K823532 | Stock #64091-PEDIATRIC Oxygen MaskBYG · Traditional | 01/05/1983SE |
| K811404 | TravelaireCCQ · Traditional | 06/09/1981SE |
| K802644 | Emerg. Oxygen Kit #65350 & #65399 CaseCAN · Traditional | 12/22/1980SE |
Questions and answers
When was Intermittent Mandatory Ventilation cleared by the FDA?
Intermittent Mandatory Ventilation (K760680) received a 510(k) decision of Substantially Equivalent on September 27, 1976, 7 days after the submission was received.
What is the product code of K760680?
The FDA product code is CBO – Attachment, Intermittent Mandatory Ventilation (Imv), a Class II (moderate risk) device regulated under 21 CFR 868.5955.