I.P.P.B. Manifold/Nebulizer (Circuit)
FDA 510(k) K760263 · Foregger
510(k) numberK760263
Submission
- Device name
- I.P.P.B. Manifold/Nebulizer (Circuit)
- Applicant
- Foregger
Mchenry, IL, US - Received
- July 21, 1976
- Decision date
- August 4, 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 |
|---|---|---|
| K771057 | Anesthesia MachineBSZ · Traditional | 07/05/1977SE |
Questions and answers
When was I.P.P.B. Manifold/Nebulizer (Circuit) cleared by the FDA?
I.P.P.B. Manifold/Nebulizer (Circuit) (K760263) received a 510(k) decision of Substantially Equivalent on August 4, 1976, 14 days after the submission was received.
What is the product code of K760263?
The FDA product code is CBO – Attachment, Intermittent Mandatory Ventilation (Imv), a Class II (moderate risk) device regulated under 21 CFR 868.5955.