510(k) K832271

EMERSON MODEL 3MV-AP AND 3V-AP PRESS- by J. H. Emerson Co. — Product Code CAP

K832271 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON MODEL 3MV-AP AND 3V-AP PRESS-". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
Review Panel
AN
Submission Type