510(k) K864394
K864394 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON 3MV VOLUME VENTILATOR". The FDA issued a decision of Substantially Equivalent on December 5, 1986. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1986
- Date Received
- November 6, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No