International Biophysics Corporation Afflovest
FDA 510(k) K122480 · International Biophysics Corporation
510(k) numberK122480
Submission
- Device name
- International Biophysics Corporation Afflovest
- Applicant
- International Biophysics Corporation
Austin, TX, US - Received
- August 14, 2012
- Decision date
- March 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYI – Percussor, Powered-Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5665
- Specialty
- Anesthesiology
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Questions and answers
When was International Biophysics Corporation Afflovest cleared by the FDA?
International Biophysics Corporation Afflovest (K122480) received a 510(k) decision of Substantially Equivalent on March 27, 2013, 225 days after the submission was received.
What is the product code of K122480?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.