The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Series 5000 Endoscope Console Models 5100 And 5200.
| Device ID | K912447 |
| 510k Number | K912447 |
| Device Name: | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1991-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B06751691000 | K912447 | 000 |
| B06751500020 | K912447 | 000 |