SPIROPRO
Oximeter
VIASYS HEALTHCARE GMBH
The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Spiropro.
Pre-market Notification Details
| Device ID | K092324 |
| 510k Number | K092324 |
| Device Name: | SPIROPRO |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-09-03 |
| Summary: | summary |
Trademark Results [SPIROPRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROPRO 75836444 2497020 Live/Registered |
ERESEARCH TECHNOLOGY GMBH 1999-10-29 |
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