D&K Engineering, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3005268307

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005268307
FEI Number
3005268307
Entity Name
D&K Engineering, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
15890 Bernardo Center Dr, San Diego, CA 92127, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
D&K Engineering, Inc. (Owner Number: 10044530)
Owner / Operator Contact Address
15890 Bernardo Center Drive, San Diego, CA 92127, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NeuroStar TMS Therapy System Tomcat

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2025-04-09
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2025-04-09
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2013-06-24

Official Correspondent

Dieu White

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

D&K Engineering, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038193079 D&K Engineering Services Sdn. Bhd. Ulu Tiram Johor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243700 Mag & More GmbH Apollo TMS Therapy System 2025-09-04
K231926 Neuronetics, Inc. NeuroStar Advanced Therapy System (All previously cleared models) 2024-03-22
K851403 Ventrex Laboratories, Inc. VENTREZYME ALLERGEN DATA REDUCTION SYSTEM 1985-06-21
K761290 Nuclear Medical Laboratories, Inc. COMPU-PET 300 1977-02-24
K770210 G.D. Searle and Co. ANALYTIX AUTO SAMPLE PREP. STA. 1600 1977-02-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2013 Beckman Coulter Inc. 1
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012 Beckman Coulter Inc. 1
Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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3007147067 NEXSTIM PLC Helsinki Uusimaa, FI
3003144120 SPARTRONICS STRONGSVILLE, INC. Strongsville, OH, US
8021774 THE MAGSTIM COMPANY LTD. Carmarthenshire Wales, GB
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005268307. Last updated year: 2026. Please use registration number 3005268307 when referencing this establishment in official correspondence.
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