The following data is part of a premarket notification filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh with the FDA for Hi-flo Therme Pneu 45, Wisap #7083, 7083v.
| Device ID | K031014 |
| 510k Number | K031014 |
| Device Name: | HI-FLO THERME PNEU 45, WISAP #7083, 7083V |
| Classification | Insufflator, Laparoscopic |
| Applicant | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Contact | Horst Semm |
| Correspondent | Horst Semm WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-06-27 |