Klarity Bolus
FDA 510(k) K202747 · Klarity Medical & Equipment (GZ) Co., Ltd.
510(k) numberK202747
Submission
- Device name
- Klarity Bolus
- Applicant
- Klarity Medical & Equipment (GZ) Co., Ltd.
Guangzhou, CN - Received
- September 21, 2020
- Decision date
- May 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Klarity Bolus cleared by the FDA?
Klarity Bolus (K202747) received a 510(k) decision of Substantially Equivalent on May 14, 2021, 235 days after the submission was received.
What is the product code of K202747?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.