Emerson 3MV Volume Ventilator
FDA 510(k) K864379 · J. H. Emerson Co.
510(k) numberK864379
Submission
- Device name
- Emerson 3MV Volume Ventilator
- Applicant
- J. H. Emerson Co.
Cambridge, MA, US - Received
- November 5, 1986
- Decision date
- December 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingNHJ · Special | 11/22/2000SE |
| K920910 | Oxygen Powered Resuscitator for CPRBTL · Traditional | 01/12/1993SE |
| K924174 | Emerson In-Exsufflator, Models 2-CM & 2-CANHJ · Traditional | 11/17/1992SE |
| K902764 | Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional | 11/19/1990SE |
| K896721 | Model 7-AT Treatment ChamberLGM · Traditional | 01/22/1990SE |
| K881808 | Emerson Chest Respirator, Model 33-CREBYT · Traditional | 08/04/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | 12/29/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K864394 | Emerson 3MV Volume Ventilator · Traditional | 12/05/1986SE |
Questions and answers
When was Emerson 3MV Volume Ventilator cleared by the FDA?
Emerson 3MV Volume Ventilator (K864379) received a 510(k) decision of Substantially Equivalent on December 15, 1986, 40 days after the submission was received.
What is the product code of K864379?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.