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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K954486
Device Name MERCURY AIRWAY PRESSURE MANOMETER
Applicant
Mercury Medical
11300-A 49th St. N.
Clearwater,  FL  34622 -4800
Applicant Contact KATHY L HANN
Correspondent
Mercury Medical
11300-A 49th St. N.
Clearwater,  FL  34622 -4800
Correspondent Contact KATHY L HANN
Regulation Number868.2600
Classification Product Code
CAP  
Date Received09/27/1995
Decision Date 04/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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