The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Joimax Endoscope/multiscope, Thessys Foraminoscope/multiscope, Thessys Laminoscope/multiscope.
| Device ID | K051827 |
| 510k Number | K051827 |
| Device Name: | JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE |
| Classification | Arthroscope |
| Applicant | JOIMAX GMBH 718 UNIVERSITY AVE., SUITE 116 Los Gatos, CA 95032 |
| Contact | Karin Gastineau |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-07-06 |
| Decision Date | 2005-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250337118473 | K051827 | 000 |
| 04250337100430 | K051827 | 000 |
| 04250337100447 | K051827 | 000 |
| 04250337100454 | K051827 | 000 |
| 04250337100485 | K051827 | 000 |
| 04250337100492 | K051827 | 000 |
| 04250337105756 | K051827 | 000 |
| 04250337105763 | K051827 | 000 |
| 04250337105770 | K051827 | 000 |
| 04250337100423 | K051827 | 000 |
| 04250337100041 | K051827 | 000 |
| 04250337118480 | K051827 | 000 |
| 04250337117650 | K051827 | 000 |
| 04250337118404 | K051827 | 000 |
| 04250337118411 | K051827 | 000 |
| 04250337100003 | K051827 | 000 |
| 04250337100010 | K051827 | 000 |
| 04250337100027 | K051827 | 000 |
| 04250337100034 | K051827 | 000 |
| 04250337105787 | K051827 | 000 |
| 04250337105794 | K051827 | 000 |
| 04250337105800 | K051827 | 000 |
| 04250337111252 | K051827 | 000 |
| 04250337114321 | K051827 | 000 |
| 04250337114680 | K051827 | 000 |
| 04250337114697 | K051827 | 000 |
| 04250337116011 | K051827 | 000 |
| 04250337116028 | K051827 | 000 |
| 04250337116318 | K051827 | 000 |
| 04250337116325 | K051827 | 000 |
| 04250337111245 | K051827 | 000 |
| 04250337111238 | K051827 | 000 |
| 04250337105879 | K051827 | 000 |
| 04250337109600 | K051827 | 000 |
| 04250337109617 | K051827 | 000 |
| 04250337109662 | K051827 | 000 |
| 04250337109679 | K051827 | 000 |
| 04250337110576 | K051827 | 000 |
| 04250337110583 | K051827 | 000 |
| 04250337111221 | K051827 | 000 |
| 04250337117643 | K051827 | 000 |