510(k) K090269
- Device
- AIRSTRIP OB
- Applicant
- AIRSTRIP TECHNOLOGIES, LP
- 510(k) number
- K090269
- Product code
- HGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-13
- Date received
- 2009-02-03
- Regulation
- 884.2740
- Classification name
- System, Monitoring, Perinatal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- WM CAMERON POWELL
- Address
- 3303 Oakwell Ct., Suite 200 San Antonio TX US 78218 78218
FDA Registration Numbers#
- 3007309299
- 9615396
- 9710602
- 3012528160
- 1450908
- 2132111
- 3010395077
- 3013596024
- 3007734888
- 3004526608
- 3008403701
- 3008717264
- 3013500228
- 3001570235
- 1000122786
- 3004566918
- 3006179052
- 9610816
- 9680215
- 3014541700
- 3010611950
- 3014220748
- 3012359877
- 3013783488
- 1121996
- 3003971136
- 3021635975
- 9617277
- 3016701404
- 1424263
- 3009499478
- 3009077524
- 3016618143
- 1066270
- 3010390468
- 2028916
- 3004167720
- 1000576299
- 3015529350
- 1218950
- 3007607999
- 3008729547
- 3007048259
- 1930027
- 1000589001
- 3013400897
- 3010698831
- 3013546957
- 9681377
- 9610105
- 3000126629
- 3004423584
- 3003681187
- 3036470679
- 3006104191
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253021 | ANNE Maternal | Sibel Health, Inc. | 2026-02-26 |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-09-19 |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025-08-27 |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-02-03 |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | 2025-01-10 |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023-12-08 |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | 2023-02-13 |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020-06-24 |
| K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018-09-10 |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. | 2018-08-30 |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018-04-23 |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017-09-06 |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC | 2017-08-24 |
Legacy Summary#
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FDA Review#
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