The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005.
| Device ID | K002572 |
| 510k Number | K002572 |
| Device Name: | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 |
| 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 | 2000-08-18 |
| Decision Date | 2000-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994840240 | K002572 | 000 |
| 00643169103597 | K002572 | 000 |
| 00643169103580 | K002572 | 000 |
| 00643169103573 | K002572 | 000 |
| 00643169103566 | K002572 | 000 |
| 00613994965622 | K002572 | 000 |