NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01


Device Classification Name

gas-machine, anesthesia

510(k) Number K080175
Device Name NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
Applicant
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 macarthur blvd.
mahwah, 
NJ 
07430 -0619

Applicant Contact kathleen kramer
Correspondent
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 macarthur blvd.
mahwah, 
NJ 
07430 -0619

Correspodent Contact kathleen kramer
Regulation Number 868.5160
Classification Product Code
BSZ  
Date Received 01/24/2008
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls