Bioflux Software II
FDA 510(k) K201040 · Biotricity
510(k) numberK201040
Submission
- Device name
- Bioflux Software II
- Applicant
- Biotricity
Redwood City, CA, US - Received
- April 1, 2020
- Decision date
- July 29, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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Questions and answers
When was Bioflux Software II cleared by the FDA?
Bioflux Software II (K201040) received a 510(k) decision of Substantially Equivalent on July 29, 2020, 119 days after the submission was received.
What is the product code of K201040?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.