DANLEE MEDICAL PRODUCTS, INC.

FDA Device Registration & Listing · Mattydale, NY, US · Registration 3004531359

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
3004531359
FEI Number
3004531359
Entity Name
DANLEE MEDICAL PRODUCTS, INC.
City/State/Country
Mattydale, NY, US
Establishment Address
BLDG. 5, 6075 EAST MOLLOY RD., Mattydale, NY 13211, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
DANLEE MEDICAL PRODUCTS, INC. (Owner Number: 9067459)
Owner / Operator Contact Address
BLDG. 5, 6075 EAST MOLLOY RD., --, Syracuse, NY 13211, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K931457
PMA Number
N/A

All Registered Proprietary Names

Hook-Up Kits (Holter Kits)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2007-12-04

Official Correspondent

JONI WALTON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DANLEE MEDICAL PRODUCTS, 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
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004531359. Last updated year: 2026. Please use registration number 3004531359 when referencing this establishment in official correspondence.
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