510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Leltek Inc.

New Taipei City, TW

Leltek Inc. appears in FDA device records in New Taipei City, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Leltek Inc. between 2020 and 2025. The busiest year on record is 2020, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Leltek Inc., by decision year
YearClearances
20201
20211
20221
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)IYNSubstantially Equivalent
K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound ImagingIYNSubstantially Equivalent
K222365Leltek Ultrasound Imaging System (Model: LU700 Series)IYNSubstantially Equivalent
K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)IYNSubstantially Equivalent
K191235Leltek Ultrasound Imaging SystemIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Leltek Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30145554553014555455Leltek Inc.6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,, New Taipei City 23147 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain