The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Clean Peak Flow Meter.
| Device ID | K091412 |
| 510k Number | K091412 |
| Device Name: | CLEAN PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| 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 | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000313 | K091412 | 000 |
| 04057155000306 | K091412 | 000 |