The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cascade Iomax Intraoperative Monitor.
| Device ID | K162199 |
| 510k Number | K162199 |
| Device Name: | Cascade IOMAX Intraoperative Monitor |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CADWELL INDUSTRIES, INC. 909 NORTH KELLOGG STREET Kennewick, WA 99336 |
| Contact | Melissa Kirkup |
| Correspondent | Melissa Kirkup CADWELL INDUSTRIES, INC. 909 NORTH KELLOGG STREET Kennewick, WA 99336 |
| Product Code | GWF |
| Subsequent Product Code | DQA |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | GZO |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067100653 | K162199 | 000 |
| 00840067102831 | K162199 | 000 |
| 00840067102862 | K162199 | 000 |
| 00840067102053 | K162199 | 000 |
| 00840067102220 | K162199 | 000 |
| 00840067102244 | K162199 | 000 |
| 00840067102657 | K162199 | 000 |
| 00840067102664 | K162199 | 000 |
| 00840067102671 | K162199 | 000 |
| 00840067102688 | K162199 | 000 |
| 00840067102763 | K162199 | 000 |
| 00840067102718 | K162199 | 000 |
| 00840067100639 | K162199 | 000 |
| 00840067100646 | K162199 | 000 |
| 00840067103616 | K162199 | 000 |