510(k) K232603
- Device
- CamAPS FX
- Applicant
- Camdiab , Ltd.
- 510(k) number
- K232603
- Product code
- QJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-23
- Date received
- 2023-08-28
- Regulation
- 862.1356
- Classification name
- Interoperable Automated Glycemic Controller
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Roman Hovorka
- Address
- 20-22 Wenlock Rd. London GB N1 7GU N1 7GU
FDA Registration Numbers
- 3007981285
- 2032227
- 3013756811
- 2246552
- 3015192982
- 3016798778
- 1220973
- 3016540876
- 3019004087
- 3008824097
- 3014585508
- 1220477
- 3026266833
Source Documents
510(k) summary PDF not indicated by FDA
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