The following data is part of a premarket notification filed by Biopsybell S.r.l. with the FDA for Diskom.
| Device ID | K180315 |
| 510k Number | K180315 |
| Device Name: | DISKOM |
| Classification | Arthroscope |
| Applicant | Biopsybell S.r.l. Via A. Manuzio N.24 Mirandola, IT 41037 |
| Contact | Tiziana Bellini |
| Correspondent | Maurizio Pantaleoni Isemed Srl Via P. Togliatti 19/X Imola, IT 40026 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-05 |
| Decision Date | 2018-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033860019747 | K180315 | 000 |
| 08033860019693 | K180315 | 000 |