The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Modification To Flowscreen.
| Device ID | K062011 |
| 510k Number | K062011 |
| Device Name: | MODIFICATION TO FLOWSCREEN |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | VIASYS HEALTHCARE GMBH 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd VIASYS HEALTHCARE GMBH 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-17 |
| Decision Date | 2007-05-11 |