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
|
|
|