EXPD 4343N1 +9 more— 510(k) K243443
Substantially EquivalentDRTECH Corporation
FDA 510(k) clearance K243443 for EXPD 4343N1 +9 more, Substantially Equivalent on 2025-03-19. Applicant: DRTECH Corporation. Device class: 2.
Clearance details
- Device name as filed
- EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
- Applicant
- DRTECH Corporation
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gyeonggi-Do, KR
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