The following data is part of a premarket notification filed by Jk-holding Gmbh with the FDA for Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / Ac / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound.
| Device ID | K190173 |
| 510k Number | K190173 |
| Device Name: | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound |
| Classification | Booth, Sun Tan |
| Applicant | JK-Holding GmbH Koehlershohner Strabe 60 Windhagen, DE 53578 |
| Contact | Juergen Gerstenmeier |
| Correspondent | Juergen Gerstenmeier JK-Holding GmbH Koehlershohner Strabe 60 Windhagen, DE 53578 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EJKP100003603A0 | K190173 | 000 |
| EJKP100003744A0 | K190173 | 000 |