The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Vip Pulmonary Function System.
| Device ID | K080510 |
| 510k Number | K080510 |
| Device Name: | VIP PULMONARY FUNCTION SYSTEM |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Contact | Thomas Rust |
| Correspondent | Thomas Rust VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-08-20 |