The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Ob.
| Device ID | K090061 |
| 510k Number | K090061 |
| Device Name: | AIRSTRIP OB |
| Classification | System, Monitoring, Perinatal |
| Applicant | AIRSTRIP TECHNOLOGIES, LP 3303 OAKWELL CT., SUITE 200 San Antonio, TX 78218 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-09 |
| Decision Date | 2009-01-23 |