AIRSTRIP REMOTE PATIENT MONITORING (RPM)


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K110503
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM)
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 oakwell ct., suite 200
san antonio, 
TX 
78218

Applicant Contact andy miller
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 02/22/2011
Decision Date 03/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party Yes

Combination Product

No