510(k) K240007
- Device
- Solar Compact (G4-1)
- Applicant
- Laborie Medical Technologies, Corp.
- 510(k) number
- K240007
- Product code
- FFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-06
- Date received
- 2024-01-02
- Regulation
- 876.1725
- Classification name
- System, Gastrointestinal Motility (Electrical)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Ingrid Dirtzu
- Address
- 180 International Dr. Portsmouth NH US 03801 03801
FDA Registration Numbers
- 9681384
- 3010082909
- 9611896
- 3008717264
- 3009106214
- 3007662958
- 9710107
- 9611668
- 3002821211
- 3016544248
- 3008361498
- 3012480535
- 3013973539
- 3017448360
- 1119033
- 1123137
- 3002806603
- 3009445917
- 8020893
- 3035451914
- 3015198783
- 3010381606
- 1836324
- 3011790297
- 3004904811
- 1126271
- 3018094310
- 3016854619
- 3008414621
- 3012302888
- 2023374
Source Documents
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