The following data is part of a premarket notification filed by St. Jude Medical Systems Ab with the FDA for Ao Usb Receiver, Wi-box, Wi-box Psu Kit, Wi-box Xpress Cable, Pw Usb Receiver.
| Device ID | K111854 |
| 510k Number | K111854 |
| Device Name: | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ST. JUDE MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-751 35 |
| Contact | Mikael Sjolander |
| Correspondent | Mikael Sjolander ST. JUDE MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-751 35 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-29 |
| Decision Date | 2011-10-21 |
| Summary: | summary |