DigitalDiagnost
FDA 510(k) clearance K210692 · decided 2021-04-02
Clearance details
- K-number
- K210692
- Device name
- DigitalDiagnost
- Applicant
- Philips Medical Systems Dmc GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-03-08
- Decision date
- 2021-04-02
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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