BR-FHUS Navigation 1.0
FDA 510(k) K171309 · Taihao Medical, Inc.
510(k) numberK171309
Submission
- Device name
- BR-FHUS Navigation 1.0
- Applicant
- Taihao Medical, Inc.
Taipei, TW - Received
- May 3, 2017
- Decision date
- September 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BR-FHUS Navigation 1.0 cleared by the FDA?
BR-FHUS Navigation 1.0 (K171309) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 149 days after the submission was received.
What is the product code of K171309?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.