FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Sonicaid Team3
K Number: K250777
·
Decision Sep 19, 2025
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
8
Review Days
189
Basic Information
- Device Name
- Sonicaid Team3
- K Number
- K250777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huntleigh Healthcare , Ltd.
- Date Received
- March 14, 2025
- Decision Date
- September 19, 2025
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Huntleigh Healthcare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241368 | Sonicaid Team3 | Feb 3, 2025 | Substantially Equivalent |
| K211200 | WoundExpress | Sep 3, 2021 | Substantially Equivalent |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Sep 6, 2019 | Substantially Equivalent |
| K152228 | Hydroven 12, Hydroven 12 Garments | Apr 4, 2016 | Substantially Equivalent |
| K090285 | SONICAID FM820 AND FM830 ENCORE | Jul 15, 2009 | Substantially Equivalent |
| K081572 | SMARTSIGNS MINPULSE | Oct 1, 2008 | Substantially Equivalent |
| K060230 | DOPPLEX CENTRALE | Mar 23, 2006 | Substantially Equivalent |