The following data is part of a premarket notification filed by Intronix Technologies Corp. with the FDA for Myoguide System Model 8008.
| Device ID | K111985 |
| 510k Number | K111985 |
| Device Name: | MYOGUIDE SYSTEM MODEL 8008 |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | INTRONIX TECHNOLOGIES CORP. 611 WEST 5TH STREET Austin, TX 78701 |
| Contact | Richard Vincins, Cqa, Rac (us,eu) |
| Correspondent | Richard Vincins, Cqa, Rac (us,eu) INTRONIX TECHNOLOGIES CORP. 611 WEST 5TH STREET Austin, TX 78701 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-12 |
| Decision Date | 2011-12-30 |
| Summary: | summary |