The following data is part of a premarket notification filed by Diagnostic Data, Inc. with the FDA for Bonart Art-e1 Electrosurgery Unit.
| Device ID | K020080 |
| 510k Number | K020080 |
| Device Name: | BONART ART-E1 ELECTROSURGERY UNIT |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | DIAGNOSTIC DATA, INC. 1342-D NORTH BENSON AVE. Upland, CA 91786 |
| Contact | Robert E Johnson |
| Correspondent | Robert E Johnson DIAGNOSTIC DATA, INC. 1342-D NORTH BENSON AVE. Upland, CA 91786 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-09 |
| Decision Date | 2002-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873121267 | K020080 | 000 |
| 04719873120185 | K020080 | 000 |
| 04719873120178 | K020080 | 000 |
| 04719873120161 | K020080 | 000 |
| 04719873120048 | K020080 | 000 |
| 04719873121342 | K020080 | 000 |
| 04719873121335 | K020080 | 000 |
| 04719873121328 | K020080 | 000 |
| 04719873121311 | K020080 | 000 |
| 04719873121304 | K020080 | 000 |
| 04719873121298 | K020080 | 000 |
| 04719873120468 | K020080 | 000 |
| 04719873120475 | K020080 | 000 |
| 04719873121250 | K020080 | 000 |
| 04719873121243 | K020080 | 000 |
| 04719873121236 | K020080 | 000 |
| 04719873121229 | K020080 | 000 |
| 04719873121212 | K020080 | 000 |
| 04719873120529 | K020080 | 000 |
| 04719873120512 | K020080 | 000 |
| 04719873120505 | K020080 | 000 |
| 04719873120499 | K020080 | 000 |
| 04719873120482 | K020080 | 000 |
| 04719873121281 | K020080 | 000 |