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FDA 510(k)

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

K 號：K243443 · 2025-03-19

申請人DRTECH Corporation
決定日期2025-03-19
產品代碼MQB
諮詢委員會RA
決定相當於

器材摘要

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K243443. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP?

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is DRTECH Corporation. The 510(k) number is K243443.

When did EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP receive FDA 510(k) clearance?

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP received FDA 510(k) clearance on 2025-03-19, under 510(k) number K243443.

Who is the listed applicant for EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP?

FDA 510(k) 記錄將 DRTECH Corporation 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP?

The FDA product code for EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP is MQB.

其他以 DRTECH Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260227EXSYS DEXi (EXSYS DEXi-S40S)；EXSYS DEXi (EXSYS DEXi-S40P)；EXSYS DEXi (EXSYS DEXi-S40T)；EXSYS DEXi (EXSYS DEXi-S50H)K261413EXTRON 3;EXTRON 6K250010EXTRON 3；EXTRON 5；EXTRON 7K242770EXPD 114；EXPD 114G；EXPD 114P；EXPD 114PGK242591XERO-alphaK242847EXSYS DEXi (EXSYS DEXi-D401S-FRM)；EXSYS DEXi (EXSYS DEXi-A401S-FRM)；EXSYS DEXi (EXSYS DEXi-D402S-FRM)；EXSYS DEXi (EXSYS DEXi-A402S-FRM)；EXSYS DEXi (EXSYS DEXi-D401P-FRM)；EXSYS DEXi (EXSYS DEXi-A401P-FRM)；EXSYS DEXi (EXSYS DEXi-D402P-FRM)；EXSYS DEXi (EXSYS DEXi-D503T-FRM)；EXSYS DEXi (EXSYS DEXi-A503T-FRM)；EXSYS DEXi (EXSYS DEXi-D401S-FRA)；EXSYS DEXi (EXSYS DEXi-D402S-FRA)；EXSYS DEXi (EXSYS DEXi-D401P-FRA)；EXSYS DEXi (EXSYS DEXi-D402P-FRA)；

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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