510(k) K954486

MERCURY AIRWAY PRESSURE MANOMETER by Mercury Medical — Product Code CAP

K954486 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY AIRWAY PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on Apr 25, 1996. 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. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 25, 1996
Date Received
Sep 27, 1995
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