Hyper Insight - ICH— 510(k) K240353
Substantially EquivalentSk, Inc.
FDA 510(k) clearance K240353 for Hyper Insight - ICH, Substantially Equivalent on 2024-07-01. Applicant: Sk, Inc.. Device class: 2.
Clearance details
- Applicant
- Sk, Inc.
- Product code
- Code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seongnam-Si, KR
Recent devices under product code QAS
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