The following data is part of a premarket notification filed by Viasys Neuro Care with the FDA for Pioneer Tc8080, Companion Iii.
| Device ID | K053648 |
| 510k Number | K053648 |
| Device Name: | PIONEER TC8080, COMPANION III |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | VIASYS NEURO CARE 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring VIASYS NEURO CARE 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-30 |
| Decision Date | 2006-01-24 |
| Summary: | summary |