The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,.
| Device ID | K010341 |
| 510k Number | K010341 |
| Device Name: | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, |
| Classification | Endoscope, Neurological |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Janet Mcauley |
| Correspondent | Janet Mcauley MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-05 |
| Decision Date | 2001-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169103542 | K010341 | 000 |
| 00643169498266 | K010341 | 000 |
| 00643169498273 | K010341 | 000 |
| 00643169498280 | K010341 | 000 |
| 00643169498297 | K010341 | 000 |
| 00643169103498 | K010341 | 000 |
| 00643169103504 | K010341 | 000 |
| 00643169103511 | K010341 | 000 |
| 00643169103528 | K010341 | 000 |
| 00643169103535 | K010341 | 000 |
| 00643169498259 | K010341 | 000 |