RESPONDER 3000


codes

Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K000638
Device Name RESPONDER 3000
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
munzinger str. 3
freiburg, 

DE

79111

Original Contact klaus rudolf
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   LDD  
Date Received 02/25/2000
Decision Date 10/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No