MODIFICATION TO NC-STAT
FDA 510(k) clearance K041320 · decided 2004-08-12
Clearance details
- K-number
- K041320
- Device name
- MODIFICATION TO NC-STAT
- Applicant
- Neurometrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-18
- Decision date
- 2004-08-12
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JXE
- Device class
- 2
- Regulation number
- 882.1550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Neurometrix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NM-01/CPT neurometer (NM-01/CPT) (K240189) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025-03-26 |
| Mediracer NCS (K190536) | Mediracer OY | 2019-09-25 |
| NEUROMETRIX ADVANCE (K070109) | Neurometrix, Inc. | 2008-04-25 |
| NC-STAT (K060584) | Neurometrix, Inc. | 2006-07-31 |
| XLTEK NEUROPATH, MODEL PK1070 (K053058) | Excel Tech. , Ltd. | 2006-02-07 |
| VIRTUAL MEDICAL SYSTEMS MODEL VT3000 (K052904) | Scientific Imaging, Inc. | 2005-10-27 |
| MODIFICATION OF NC-STAT (K013459) | Neurometrix, Inc. | 2002-01-17 |
| MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (K012069) | Neurotron Medical, Inc. | 2001-08-01 |
| NC-STAT (K003508) | Neurometrix, Inc. | 2001-01-17 |
| NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (K001692) | Neurosoft, Inc. | 2000-11-24 |
| MODIFICATION TO NC-STAT (K000565) | Neurometrix, Inc. | 2000-06-27 |
| NC-STAT (K982359) | Neurometrix, Inc. | 1998-10-02 |
Recalls involving this device
No recalls on record reference this clearance.