INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
FDA 510(k) clearance K935298 · decided 1994-08-03
Clearance details
- K-number
- K935298
- Device name
- INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
- Applicant
- Insta Nerve Canada, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-02
- Decision date
- 1994-08-03
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- JXE
- Device class
- 2
- Regulation number
- 882.1550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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| VIRTUAL MEDICAL SYSTEMS MODEL VT3000 (K052904) | Scientific Imaging, Inc. | 2005-10-27 |
| MODIFICATION TO NC-STAT (K041320) | Neurometrix, Inc. | 2004-08-12 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.