510(k) K864394

EMERSON 3MV VOLUME VENTILATOR by J. H. Emerson Co.

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