EXPD 4343N1 +9 more— 510(k) K243443

Substantially Equivalent

DRTECH 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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