ARIATELE TELEMETRY TRANSMITTER (96281)


Device Classification Name

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

510(k) Number K121480
Device Name ARIATELE TELEMETRY TRANSMITTER (96281)
Applicant
SPACELABS HEALTHCARE
p.o. box 3018
nederland, 
CO 
80466

Applicant Contact thomas kroenke
Correspondent
SPACELABS HEALTHCARE
p.o. box 3018
nederland, 
CO 
80466

Correspodent Contact thomas kroenke
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 05/18/2012
Decision Date 06/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls