The following data is part of a premarket notification filed by Abbott Medical with the FDA for Ionicrf Generator.
| Device ID | K201610 |
| 510k Number | K201610 |
| Device Name: | IonicRF Generator |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | Abbott Medical 5050 Nathan Lane Plymouth, MN 55442 |
| Contact | Jim Chapman |
| Correspondent | Jim Chapman Abbott Medical 5050 Nathan Lane Plymouth, MN 55442 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067033833 | K201610 | 000 |
| 05415067029317 | K201610 | 000 |