The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Telepack +.
| Device ID | K193235 |
| 510k Number | K193235 |
| Device Name: | Telepack + |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551425701 | K193235 | 000 |