The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Accuguide Muscle Injection Monitor.
| Device ID | K990793 |
| 510k Number | K990793 |
| Device Name: | ACCUGUIDE MUSCLE INJECTION MONITOR |
| Classification | Electrode, Needle |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | David Timlin |
| Correspondent | David Timlin MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | GXZ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | IKT |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-10 |
| Decision Date | 1999-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994161635 | K990793 | 000 |
| 20643169345007 | K990793 | 000 |
| 20643169344994 | K990793 | 000 |
| 00643169294332 | K990793 | 000 |
| 00643169294325 | K990793 | 000 |