Polygram Net Biofeedback Application
FDA 510(k) K041244 · Medtronic Vascular
510(k) numberK041244
Submission
- Device name
- Polygram Net Biofeedback Application
- Applicant
- Medtronic Vascular
Shoreview, MN, US - Received
- May 11, 2004
- Decision date
- August 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Polygram Net Biofeedback Application cleared by the FDA?
Polygram Net Biofeedback Application (K041244) received a 510(k) decision of Substantially Equivalent on August 12, 2004, 93 days after the submission was received.
What is the product code of K041244?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.