510(k) K143114
- Device
- Sense4Baby System Model B+ (MSA)
- Applicant
- AIRSTRIP TECHNOLOGIES, INC.
- 510(k) number
- K143114
- Product code
- LQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-10
- Date received
- 2014-10-30
- Regulation
- 884.2730
- Classification name
- Home Uterine Activity Monitor
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT ANDREW MILLER
- Address
- 565 Plearl St. Suite 209 La Jolla CA US 92037 92037
FDA Registration Numbers#
- 3010032952
- 3016829704
Source Documents#
Other 510(k) Records For Product Code LQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253673 | M•care System (MW-20) | Marani Health, Inc. | 2026-09-03 |
| K221046 | Invu by Nuvo | Nuvo- Group , Ltd. | 2022-05-06 |
| K210025 | INVU by Nuvo | Nuvo- Group , Ltd. | 2021-05-28 |
| K191401 | PregSense | Nuvo- Group , Ltd. | 2020-03-27 |
| K020390 | MODIFICATION TO FETAL ASSIST | Huntleigh Diagnostics , Ltd. | 2002-04-19 |
Legacy Summary#
summary
FDA Review#
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