510(k) K000565
- Device
- MODIFICATION TO NC-STAT
- Applicant
- NEUROMETRIX, INC.
- 510(k) number
- K000565
- Product code
- JXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-06-27
- Date received
- 2000-02-22
- Regulation
- 882.1550
- Classification name
- Device, Nerve Conduction Velocity Measurement
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA J.M. NOLTE
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 1067162
- 8030229
- 3024996452
- 3013501110
- 9611252
- 3011790297
- 3008881376
- 3006697681
- 3001687738
- 3010611950
- 2022388
- 9611896
- 3007962724
- 2023374
- 3020018
- 3005581270
- 2184161
- 3006418479
- 3016852448
- 3008773490
- 2080783
- 3013246402
- 3017448360
- 3012182497
- 8021774
- 2183456
Source Documents#
Other 510(k) Records For Product Code JXE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025-03-26 |
| K190536 | Mediracer NCS | Mediracer OY | 2019-09-25 |
| K070109 | NEUROMETRIX ADVANCE | Neurometrix, Inc. | 2008-04-25 |
| K060584 | NC-STAT | Neurometrix, Inc. | 2006-07-31 |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Excel Tech. , Ltd. | 2006-02-07 |
| K052904 | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | Scientific Imaging, Inc. | 2005-10-27 |
| K041320 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | 2004-08-12 |
| K013459 | MODIFICATION OF NC-STAT | Neurometrix, Inc. | 2002-01-17 |
| K012069 | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | Neurotron Medical, Inc. | 2001-08-01 |
| K003508 | NC-STAT | Neurometrix, Inc. | 2001-01-17 |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | Neurosoft, Inc. | 2000-11-24 |
| K982359 | NC-STAT | Neurometrix, Inc. | 1998-10-02 |
| K963208 | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | Neurotron Medical | 1997-07-14 |
| K935298 | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | Insta Nerve Canada, Inc. | 1994-08-03 |
| K935017 | TD50 ELECTROMYOGRAPH | Medelec Intl. Corp. | 1994-07-28 |
Legacy Summary#
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FDA Review#
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