The following data is part of a premarket notification filed by Viasys Healthcare, Inc. with the FDA for Sonara; Sonara/tek.
| Device ID | K060421 |
| 510k Number | K060421 |
| Device Name: | SONARA; SONARA/TEK |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | VIASYS HEALTHCARE, INC. 227 WASHINGTON ST. ' SUITE 200 Conshohocken, PA 19428 |
| Contact | Glen Hermanson |
| Correspondent | Glen Hermanson VIASYS HEALTHCARE, INC. 227 WASHINGTON ST. ' SUITE 200 Conshohocken, PA 19428 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-17 |
| Decision Date | 2006-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830041799 | K060421 | 000 |
| 00382830032094 | K060421 | 000 |
| 00382830032117 | K060421 | 000 |
| 00382830032223 | K060421 | 000 |
| 00382830036757 | K060421 | 000 |
| 00382830037051 | K060421 | 000 |
| 00382830037068 | K060421 | 000 |
| 00382830037181 | K060421 | 000 |
| 00382830037679 | K060421 | 000 |
| 00382830031530 | K060421 | 000 |