The following data is part of a premarket notification filed by Thermedx Llc with the FDA for Thermedx Fluid Managment System.
| Device ID | K133799 |
| 510k Number | K133799 |
| Device Name: | THERMEDX FLUID MANAGMENT SYSTEM |
| Classification | Insufflator, Hysteroscopic |
| Applicant | THERMEDX LLC 31200 SOLON RD., UNIT #1 Solon, OH 44139 |
| Contact | Jeff Williams |
| Correspondent | Jeff Williams THERMEDX LLC 31200 SOLON RD., UNIT #1 Solon, OH 44139 |
| Product Code | HIG |
| Subsequent Product Code | HRX |
| Subsequent Product Code | LGZ |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-06-20 |
| Summary: | summary |