Data / Medical devices / United States / Danlee Medical Products, Inc.
Danlee Medical Products, Inc.: FDA-registered device maker in Mattydale, NY, United States, 1 510(k) clearance
Danlee Medical Products, Inc. is registered with the FDA (registration 3004531359) in Mattydale, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 23, 1993. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004531359
- Address
- BLDG. 5, 6075 East Molloy RD., Mattydale, NY, United States, 13211
- Owner or operator
- DANLEE MEDICAL PRODUCTS, INC. (9067459)
- Roles
- Repackager or relabeler
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- Hook-Up Kits (Holter Kits)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 1993 | K931457 | NDM SILVON ECG ELECTRODES | DRX | Substantially Equivalent | Ndm Acquisition Corp. | accessdata.fda.gov |
Compare with other makers
Updated November 23, 1993. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.