Device Classification Name |
system, network and communication, physiological monitors
|
510(k) Number |
K160862 |
Device Name |
AirStrip RPM |
Applicant |
AirStrip Technologies, Inc. |
335 E. Sonterra Blvd, Suite 200 |
san antonio,
TX
78258
|
|
Applicant Contact |
andy miller |
Correspondent |
Certified Compliance Solutions, Inc. |
11665 Avena Place #203 |
san diego,
CA
92128 -2504
|
|
Correspondent Contact |
curtis m. egan |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 03/29/2016 |
Decision Date | 09/19/2016 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|