JLK-ICH— 510(k) K243363
Substantially EquivalentJLK, Inc.
FDA 510(k) clearance K243363 for JLK-ICH, Substantially Equivalent on 2025-01-03. Applicant: JLK, Inc.. Device class: 2.
Clearance details
- Applicant
- JLK, 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
- Seoul, KR
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