The following data is part of a premarket notification filed by Neurotron Medical, Inc. with the FDA for Modification To:brevio Nerve Conduction Test Instrument.
| Device ID | K012069 |
| 510k Number | K012069 |
| Device Name: | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROTRON MEDICAL, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville, MD 20852 |
| Contact | Whitt Athey |
| Correspondent | Whitt Athey NEUROTRON MEDICAL, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville, MD 20852 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1870223 | K012069 | 000 |