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
|
|
Correspondent Contact |
THOMAS KROENKE |
Regulation Number | 870.1025
|
Classification Product Code |
|
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
|
|
|