The following data is part of a premarket notification filed by Thermedx, Llc with the FDA for Thermedx Prodigy Fluid Management System, Models P1000, P2000.
| Device ID | K091939 |
| 510k Number | K091939 |
| Device Name: | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | THERMEDX, LLC 31200 SOLON ROAD UNIT 1 Solon, OH 44139 |
| Contact | Jeff B Williams |
| Correspondent | Jeff B Williams THERMEDX, LLC 31200 SOLON ROAD UNIT 1 Solon, OH 44139 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2010-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20860936000352 | K091939 | 000 |
| 20860936000345 | K091939 | 000 |
| 20860936000338 | K091939 | 000 |
| 00860936000327 | K091939 | 000 |
| 00860936000310 | K091939 | 000 |