The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Neuropen Endoscope And Optical Accessories.
| Device ID | K003914 |
| 510k Number | K003914 |
| Device Name: | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES |
| 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 | 2000-12-19 |
| Decision Date | 2001-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908490 | K003914 | 000 |
| 00613994840233 | K003914 | 000 |
| 00643169498334 | K003914 | 000 |
| 00643169498327 | K003914 | 000 |
| 00643169498310 | K003914 | 000 |
| 00643169498303 | K003914 | 000 |
| 00721902879784 | K003914 | 000 |