SpiroSphere
Calculator, Predicted Values, Pulmonary Function
EReserchTechnology GmbH
The following data is part of a premarket notification filed by Ereserchtechnology Gmbh with the FDA for Spirosphere.
Pre-market Notification Details
| Device ID | K173937 |
| 510k Number | K173937 |
| Device Name: | SpiroSphere |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | eReserchTechnology GmbH Sieboldstrasse 3 Estenfeld, DE 97230 |
| Contact | Johannes Thalhammer |
| Correspondent | Dawn M Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2019-02-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000542 | K173937 | 000 |
| 04057155000788 | K173937 | 000 |
| 04057155000719 | K173937 | 000 |
| 04057155000726 | K173937 | 000 |
| 04057155000757 | K173937 | 000 |
| 04057155000764 | K173937 | 000 |
| 04057155000351 | K173937 | 000 |
| 04057155000375 | K173937 | 000 |
| 04057155000436 | K173937 | 000 |
| 04057155000528 | K173937 | 000 |
| 04057155000535 | K173937 | 000 |
| 04057155000771 | K173937 | 000 |
Trademark Results [SpiroSphere]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROSPHERE 79126731 4513062 Live/Registered |
eResearchTechnology GmbH 2012-12-21 |
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