510(k) K133450

AIRSTRIP REMOTE PATIENT MONITORING by Airstrip Technologies, LP — Product Code MWI

K133450 is an FDA 510(k) premarket notification submitted by Airstrip Technologies, LP for the device "AIRSTRIP REMOTE PATIENT MONITORING". The FDA issued a decision of Substantially Equivalent on February 14, 2014. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Airstrip Technologies, LP has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
November 11, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type