The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for X-ray System Xr-mx.
| Device ID | K004037 |
| 510k Number | K004037 |
| Device Name: | X-RAY SYSTEM XR-MX |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Jennifer S Portugal |
| Correspondent | Jennifer S Portugal KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-28 |
| Decision Date | 2001-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039100230 | K004037 | 000 |