The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nim-prs.
| Device ID | K024316 |
| 510k Number | K024316 |
| Device Name: | NIM-PRS |
| Classification | Electromyograph, Diagnostic |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Martin Sargent |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-12-26 |
| Decision Date | 2003-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994430209 | K024316 | 000 |
| 00643169294394 | K024316 | 000 |
| 00643169294295 | K024316 | 000 |
| 20643169290079 | K024316 | 000 |
| 00643169290020 | K024316 | 000 |
| 00763000043230 | K024316 | 000 |
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| 20763000038322 | K024316 | 000 |
| 20763000038261 | K024316 | 000 |
| 20763000038063 | K024316 | 000 |
| 00763000034061 | K024316 | 000 |
| 00763000034054 | K024316 | 000 |
| 00763000033774 | K024316 | 000 |
| 00643169294400 | K024316 | 000 |
| 20643169348756 | K024316 | 000 |
| 00613994430199 | K024316 | 000 |
| 20643169938810 | K024316 | 000 |
| 20643169938803 | K024316 | 000 |
| 00643169938793 | K024316 | 000 |
| 00643169938786 | K024316 | 000 |
| 00643169938755 | K024316 | 000 |
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| 00643169938519 | K024316 | 000 |
| 00643169938489 | K024316 | 000 |
| 20643169938445 | K024316 | 000 |
| 00643169695016 | K024316 | 000 |
| 00763000034078 | K024316 | 000 |