The following data is part of a premarket notification filed by Rz Medizintechnik Gmbh with the FDA for Discoscopes, Cervical Endoscopes.
| Device ID | K130778 |
| 510k Number | K130778 |
| Device Name: | DISCOSCOPES, CERVICAL ENDOSCOPES |
| Classification | Arthroscope |
| Applicant | RZ MEDIZINTECHNIK GMBH GRIESWEG 47 Muehlheim, Baden-wuerttemberg, DE 78570 |
| Contact | Andre Weingrel |
| Correspondent | Andre Weingrel RZ MEDIZINTECHNIK GMBH GRIESWEG 47 Muehlheim, Baden-wuerttemberg, DE 78570 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-21 |
| Decision Date | 2014-04-14 |
| Summary: | summary |