The following data is part of a premarket notification filed by Medical Physics And Services, Inc. with the FDA for Mps M Electrode.
| Device ID | K002801 |
| 510k Number | K002801 |
| Device Name: | MPS M ELECTRODE |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | MEDICAL PHYSICS AND SERVICES, INC. 1091 IRMA DRIVE, UNIT C Denver, CO 80233 |
| Contact | Howard C Thomas |
| Correspondent | Howard C Thomas MEDICAL PHYSICS AND SERVICES, INC. 1091 IRMA DRIVE, UNIT C Denver, CO 80233 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2001-05-04 |