The following data is part of a premarket notification filed by Airstrip Technologies, Inc. with the FDA for Airstrip Rpm.
| Device ID | K160862 |
| 510k Number | K160862 |
| Device Name: | AirStrip RPM |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | AirStrip Technologies, Inc. 335 E. Sonterra Blvd, Suite 200 San Antonio, TX 78258 |
| Contact | Andy Miller |
| Correspondent | Curtis M. Egan Certified Compliance Solutions, Inc. 11665 Avena Place #203 San Diego, CA 92128 -2504 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2016-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B15320100 | K160862 | 000 |
| B15320030 | K160862 | 000 |