ICS Dizcovery (1091)— 510(k) K242198
Substantially EquivalentNatus Medical Denmark Aps
FDA 510(k) clearance K242198 for ICS Dizcovery (1091), Substantially Equivalent on 2025-02-14. Applicant: Natus Medical Denmark Aps. Device class: 2.
Clearance details
- Applicant
- Natus Medical Denmark Aps
- Product code
- Code GWN
- Device class
- Class 2
- Regulation
- 21 CFR 882.1460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taastrup, DK
Recent devices under product code GWN
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