Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, PW Usb Receiver
FDA 510(k) K111854 · St. Jude Medical Systems AB
510(k) numberK111854
Submission
- Device name
- Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, PW Usb Receiver
- Applicant
- St. Jude Medical Systems AB
Uppsala, SE - Received
- June 29, 2011
- Decision date
- October 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, PW Usb Receiver cleared by the FDA?
Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, PW Usb Receiver (K111854) received a 510(k) decision of Substantially Equivalent on October 21, 2011, 114 days after the submission was received.
What is the product code of K111854?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.