SpiroScout
Spirometer, Diagnostic
GANSHORN MEDIZIN ELECTRONIC GMBH
The following data is part of a premarket notification filed by Ganshorn Medizin Electronic Gmbh with the FDA for Spiroscout.
Pre-market Notification Details
| Device ID | K160116 |
| 510k Number | K160116 |
| Device Name: | SpiroScout |
| Classification | Spirometer, Diagnostic |
| Applicant | GANSHORN MEDIZIN ELECTRONIC GMBH INDUSTRIESTR 6-8 Niederlauer, DE 97618 |
| Contact | Stefan Ponto |
| Correspondent | Paul Dryden GANSHORN MEDIZIN ELECTRONIC GMBH INDUSTRIESTR 6-8 Niederlaauer, DE 97618 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-10-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250972300103 | K160116 | 000 |
| 04250972300172 | K160116 | 000 |
Trademark Results [SpiroScout]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROSCOUT 77789741 not registered Dead/Abandoned |
Reciprocal Sciences 2009-07-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.