The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Fs Ergo.
| Device ID | K173646 |
| 510k Number | K173646 |
| Device Name: | FS Ergo |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | PaloDEx Group Oy Nahkelantie 160 Tuusula, FI 04300 |
| Contact | Anni Lundholm |
| Correspondent | Anni Lundholm PaloDEx Group Oy Nahkelantie 160 Tuusula, FI 04300 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-27 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872794 | K173646 | 000 |