The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Remote Patient Monitoring Philips Adapter.
Device ID | K131786 |
510k Number | K131786 |
Device Name: | AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | AIRSTRIP TECHNOLOGIES, LP 335 E. SONTERRA BLVD. SUITE 200 San Antonio, TX 78258 |
Contact | Robert Andrew Miller |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-06-18 |
Decision Date | 2013-07-03 |