The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Neurotrac.
| Device ID | K831715 |
| 510k Number | K831715 |
| Device Name: | NEUROTRAC |
| Classification | Stimulator, Nerve |
| Applicant | HDC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-27 |
| Decision Date | 1983-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B339501120 | K831715 | 000 |
| B339500020 | K831715 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEUROTRAC 90055879 not registered Live/Pending |
Verity Medical Limited 2020-07-16 |
![]() NEUROTRAC 85642728 not registered Dead/Abandoned |
Grass Technologies Corporation 2012-06-04 |
![]() NEUROTRAC 85491373 4236463 Dead/Cancelled |
NATUS MEDICAL INCORPORATED 2011-12-09 |
![]() NEUROTRAC 78732604 3141993 Dead/Cancelled |
NATUS MEDICAL INCORPORATED 2005-10-13 |
![]() NEUROTRAC 75638163 not registered Dead/Abandoned |
Verity Medical Ltd. 1999-02-10 |
![]() NEUROTRAC 73409095 1356285 Dead/Expired |
Interspec Inc. 1983-01-12 |