SMARTLANK WIRELESS, MODEL 001970


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K033642
Device Name SMARTLANK WIRELESS, MODEL 001970
Applicant
MRL, A WELCH ALLYN COMPANY
4341 state street road
skaneateles falls, 
NY 
13153

Applicant Contact david klementowski
Correspondent
MRL, A WELCH ALLYN COMPANY
4341 state street road
skaneateles falls, 
NY 
13153

Correspodent Contact david klementowski
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 11/20/2003
Decision Date 05/25/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No