SAMARITAN AED, MODEL SAM-01


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K023854
Device Name SAMARITAN AED, MODEL SAM-01
Original Applicant
HEARTSINE TECHNOLOGIES, INC.
25892 jamon ln.
mission viejo, 
CA 
92691

Original Contact william j smirles
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 11/19/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No