Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183613

FEI Number

2183613

Entity Name

NORTECH SYSTEMS, INC.

City/State/Country

Milaca, MN, US

Establishment Address

925 SIXTH AVENUE NE, Milaca, MN 56353, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nortech Systems, Inc. (Owner Number: 10032390)

Owner / Operator Contact Address

925 6th Ave NE, Milaca, MN 56353, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EZstim III COOLIEF Quad Pump Assist MS-IVB CirQPOD Aerin Console, Model FG226 TELIGEN mcompass Mammotome elite Biopsy System UltraMist Portrait Clinical Alarming Unit (Portrait CAU01) BRS Rezum System Urgent PC Neuromodulation System Model 2740 Physician Programmer SleepSync Model 2740C Inspire Programmer Cable SleepSync Model 2740S Inspire Programming Software Application Aerin Console, Model FG2045 PATIENT WARMING SYSTEM M1000 CLEANING KIT Kimberly-Clark Patient Warming System Neoprobe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2017-03-01
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2020-02-28
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	Class 2	884.1710	2024-09-03
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2021-02-25
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2016-08-11
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2018-08-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-11
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2022-12-13
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2014-02-05
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-01-16
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-01-09
NRB	Wound Cleaner, Ultrasound	General, Plastic Surgery	Class 2	878.4410	2024-09-03
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-09-03
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-09-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-09-03
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-09-03
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-09-03
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2014-02-05
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	Class 2	884.1710	2014-11-06
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2018-05-29
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence	Gastroenterology, Urology	Class 2	876.5310	2013-07-08
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown	Class 3	N/A	2024-09-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-13
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2013-05-14
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2017-09-18

Official Correspondent

Albert Schafer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nortech Systems, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21
K860126	Burron Medical Products, Inc.	STIMUPLEX, NERVE STIMULATOR	1986-02-28
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183613. Last updated year: 2026. Please use registration number 2183613 when referencing this establishment in official correspondence.