Fall-Safe Imv #M-511
FDA 510(k) K791911 · Mem Medical, Inc.
510(k) numberK791911
Submission
- Device name
- Fall-Safe Imv #M-511
- Applicant
- Mem Medical, Inc.
Mchenry, IL, US - Received
- September 25, 1979
- Decision date
- October 9, 1979
- 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 |
| 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 |
| K760891 | Inspiron I.M.V. Set UpCBO · Traditional | Inspiron Corp. | 12/09/1976SE |
More from Inspiron Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K791913 | Imv Manifold #M-506CBO · Traditional | 10/09/1979SE |
| K791912 | Imv for Monitoring #M-510CBO · Traditional | 10/09/1979SE |
| K791910 | Three Liter Bag #M-512BTC · Traditional | 10/09/1979SE |
| K791909 | Imv Bushing #M-513CBO · Traditional | 10/09/1979SE |
| K791908 | Retard Valve 3-STACK #M-514CBP · Traditional | 10/09/1979SE |
| K791907 | Retard Valve 3-STACK #M-515CBP · Traditional | 10/09/1979SE |
| K791906 | Imv W/Bag #M-507CBO · Traditional | 10/09/1979SE |
| K791905 | Imv W/Bag & Tubing #M-508CBO · Traditional | 10/09/1979SE |
| K791904 | Imv W/Bag & Hoses #M-509CBO · Traditional | 10/09/1979SE |
| K791853 | Tee- Two-Way Valves M-500 · Traditional | 10/01/1979SE |
Questions and answers
When was Fall-Safe Imv #M-511 cleared by the FDA?
Fall-Safe Imv #M-511 (K791911) received a 510(k) decision of Substantially Equivalent on October 9, 1979, 14 days after the submission was received.
What is the product code of K791911?
The FDA product code is CBO – Attachment, Intermittent Mandatory Ventilation (Imv), a Class II (moderate risk) device regulated under 21 CFR 868.5955.