The following data is part of a premarket notification filed by Capenergy Medical Sl with the FDA for Capenergy - C100, C200, C300, C400, C50.
| Device ID | K191202 |
| 510k Number | K191202 |
| Device Name: | CAPENERGY - C100, C200, C300, C400, C50 |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Capenergy Medical SL Avinguda Mare De Deu De Montserrat, 41 Sant Joan Despi, Barcelona, ES 08970 |
| Contact | Pilar Sanchez |
| Correspondent | Pilar Sanchez Capenergy Medical SL Avinguda Mare De Deu De Montserrat, 41 Sant Joan Despi, Barcelona, ES 08970 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2020-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437021499056 | K191202 | 000 |
| 08437021499049 | K191202 | 000 |
| 08437021499032 | K191202 | 000 |
| 08437021499025 | K191202 | 000 |
| 08437021499018 | K191202 | 000 |