The following data is part of a premarket notification filed by Airstrip Technologies, Inc. with the FDA for Sense4baby System Model B+ (msa).
| Device ID | K143114 |
| 510k Number | K143114 |
| Device Name: | Sense4Baby System Model B+ (MSA) |
| Classification | Home Uterine Activity Monitor |
| Applicant | AIRSTRIP TECHNOLOGIES, INC. 565 PLEARL ST. SUITE 209 La Jolla, CA 92037 |
| Contact | Robert Andrew Miller |
| Correspondent | Curtis M Egan CERTIFIED COMPLIANCE SOLUTIONS, INC. 11665 AVENA PLACE, SUITE 203 San Diego, CA 92128 |
| Product Code | LQK |
| Subsequent Product Code | HGM |
| Subsequent Product Code | MOH |
| CFR Regulation Number | 884.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-30 |
| Decision Date | 2015-03-10 |
| Summary: | summary |