CRITERION 40 OR PM 40


Device Classification Name

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

510(k) Number K992101
Device Name CRITERION 40 OR PM 40
Applicant
CARADYNE, LTD.
6329 w. waterview ct.
mccordsville, 
IN 
46055

Applicant Contact paul e dryden
Correspondent
CARADYNE, LTD.
6329 w. waterview ct.
mccordsville, 
IN 
46055

Correspodent Contact paul e dryden
Regulation Number 868.2600
Classification Product Code
CAP  
Date Received 06/22/1999
Decision Date 01/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized