The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Xr-mx/1000.
| Device ID | K200965 |
| 510k Number | K200965 |
| Device Name: | XR-MX/1000 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | KARL STORZ Endoscopy America, Inc. 2151 E Grand Ave El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Mario Trujillo KARL STORZ Endoscopy America, Inc. 2151 E Grand Ave El Segundo, CA 90245 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-10 |
| Decision Date | 2020-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039101084 | K200965 | 000 |
| 07630039101053 | K200965 | 000 |
| 07630039101046 | K200965 | 000 |