Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K121871 |
Device Name |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
Applicant |
AIRSTRIP TECHNOLOGIES, LP |
335 E. SONTERRA BLVD. |
SUITE 200 |
SAN ANTONIO,
TX
78258
|
|
Applicant Contact |
ROBERT ANDREW MILLER |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 06/27/2012 |
Decision Date | 07/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|