The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Electromagnetic Transmitting Stylet.
| Device ID | K131532 |
| 510k Number | K131532 |
| Device Name: | ELECTROMAGNETIC TRANSMITTING STYLET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CORPAK MEDSYSTEMS 1001 Asbury Dr Buffalo Grove, IL 60089 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski CORPAK MEDSYSTEMS 1001 Asbury Dr Buffalo Grove, IL 60089 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2013-08-12 |