The following data is part of a premarket notification filed by Cyberonics, Inc. with the FDA for Model 220 Patient Magnet.
| Device ID | K092364 |
| 510k Number | K092364 |
| Device Name: | MODEL 220 PATIENT MAGNET |
| Classification | Magnet, Test, Pacemaker |
| Applicant | CYBERONICS, INC. 100 CYBERONICS BLVD. Houston, TX 77058 -2017 |
| Contact | Karen Stueber |
| Correspondent | Karen Stueber CYBERONICS, INC. 100 CYBERONICS BLVD. Houston, TX 77058 -2017 |
| Product Code | DTG |
| CFR Regulation Number | 870.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425025750252 | K092364 | 000 |
| 05425025750313 | K092364 | 000 |