The following data is part of a premarket notification filed by Airstrip Technologies, Inc. with the FDA for Airstrip Rpm Invisionheart Adapter.
| Device ID | K182226 |
| 510k Number | K182226 |
| Device Name: | AirStrip RPM InvisionHeart Adapter |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | AirStrip Technologies, Inc. 335 E. Sonterra Blvd., Suite #200 San Antonio, TX 78258 |
| Contact | Kirk Johnson |
| 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 | 2018-08-16 |
| Decision Date | 2018-09-11 |
| Summary: | summary |