INFINITY MODULAR MONITORS VF4 MODIFICATIONS

Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K033694
Device Name INFINITY MODULAR MONITORS VF4 MODIFICATIONS
Applicant
Draeger Medical Systems, Inc.
16 electronics ave.
danvers, 
MA 
01923

Applicant Contact penelope h greco
Correspondent
Draeger Medical Systems, Inc.
16 electronics ave.
danvers, 
MA 
01923

Correspodent Contact penelope h greco
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 11/24/2003
Decision Date 03/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No