The following data is part of a premarket notification filed by Micromed Development Corp. with the FDA for Nerve Monitor Electrodes/stimulator Probes.
| Device ID | K945242 |
| 510k Number | K945242 |
| Device Name: | NERVE MONITOR ELECTRODES/STIMULATOR PROBES |
| Classification | Stimulator, Nerve |
| Applicant | MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Contact | Dan H Trece |
| Correspondent | Dan H Trece MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1994-12-27 |