SPIROSOFT
Calculator, Predicted Values, Pulmonary Function
VIASYS HEALTHCARE GMBH
The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Spirosoft.
Pre-market Notification Details
| Device ID | K031194 |
| 510k Number | K031194 |
| Device Name: | SPIROSOFT |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | VIASYS HEALTHCARE GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Earl Draper |
| Correspondent | Earl Draper VIASYS HEALTHCARE GMBH 22705 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 | 2003-04-16 |
| Decision Date | 2003-07-30 |
Trademark Results [SPIROSOFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROSOFT 73280281 1189189 Dead/Cancelled |
ChesTech Mobile Health Service 1980-10-03 |
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