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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 K000959
Device Name CRITERION 60 OR PM 60
Applicant
CARADYNE, LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
CARADYNE, LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.2600
Classification Product Code
CAP  
Subsequent Product Code
CCL  
Date Received03/24/2000
Decision Date 06/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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