Data / Medical devices / United States / VectraCor, Inc.
VectraCor, Inc.: FDA-registered device maker in Totowa, NJ, United States, 8 510(k) clearances
VectraCor, Inc. is registered with the FDA (registration 3009443693) in Totowa, NJ, United States. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 28, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009443693
- Address
- 785 Totowa Rd Suite 100, Totowa, NJ, United States, 07512
- Owner or operator
- VectraCor, Inc. (10038931)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 25, 2011
- Registered through
- 2026
- Brand names listed
- 3L Calibration Syringe, Eidos 5003, Electrode, Holter Prep Kit, Nose Clips, Orbit Spirometer, Trillium Platinum Vet, Universal ECG and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 28, 2018 | K173952 | Universal SmartECG | DPS | Substantially Equivalent | Vectracor, Inc. | accessdata.fda.gov |
| January 30, 2015 | K140852 | VECTRAPLEX CMS | MSX | Substantially Equivalent | Vectracor, Inc. | accessdata.fda.gov |
| April 19, 2012 | K120880 | ORBIT | BZG | Substantially Equivalent | National Biomedical, LLC Dba Qrs Diagnostic | accessdata.fda.gov |
| November 2, 2011 | K102378 | VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI | DPS | Substantially Equivalent | Vectracor, Inc. | accessdata.fda.gov |
| December 9, 2010 | K102723 | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | MWJ | Substantially Equivalent | Memtec Corp. | accessdata.fda.gov |
| March 28, 2003 | K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | DRX | Substantially Equivalent | Vermont Medical, Inc. | accessdata.fda.gov |
| February 2, 1999 | K990266 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | LOS | Substantially Equivalent | Micromedical Industries, Ltd. | accessdata.fda.gov |
| July 16, 1996 | K952969 | EIDOS 5003 HOLTER SYSTEM | DQK | Substantially Equivalent | New Product Development, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of LOS
- All makers of Monitor, St Segment With Alarm
- All makers of Electrode, Electrocardiograph
- All makers of Calibrator, Volume, Gas
Updated August 28, 2018. 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.