CRITERION 60 OR PM 60


definition

Device Classification Name

monitor, airway pressure (includes gauge and/or alarm)

510(k) Number K000959
Device Name CRITERION 60 OR PM 60
Original Applicant
CARADYNE, LTD.
6329 w. waterview ct.
mccordsville, 
IN 
46055

Original Contact paul dryden
Regulation Number 868.2600
Classification Product Code
CAP  
Subsequent Product Code
CCL  
Date Received 03/24/2000
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