Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K133394 |
Device Name |
AIRSTRIP REMOTE PATIENT MONITORING |
Applicant |
AIRSTRIP TECHNOLOGIES, LP |
335 E. SONTERRA BLVD. |
SUITE 200 |
SAN ANTONIO,
TX
78258
|
|
Applicant Contact |
ROBERT A MILLER |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 11/05/2013 |
Decision Date | 02/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|