510(k) K032593

MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER by Mercury Medical — Product Code BXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2004
Date Received
August 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Airway Pressure (Inspiratory Force)
Device Class
Class II
Regulation Number
868.1780
Review Panel
AN
Submission Type