The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Becker External Drainage And Monitoring System.
| Device ID | K200456 |
| 510k Number | K200456 |
| Device Name: | Becker External Drainage And Monitoring System |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Medtronic, Inc. 125 Cremona Drive Goleta, CA 93117 |
| Contact | Nancy Hampton |
| Correspondent | Nancy Hampton Medtronic, Inc. 125 Cremona Drive Goleta, CA 93117 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-25 |
| Decision Date | 2020-03-26 |