R7
FDA 510(k) K130834 · Cefla S.C.
510(k) numberK130834
Submission
- Device name
- R7
- Applicant
- Cefla S.C.
Ormond Beach, FL, US - Received
- March 26, 2013
- Decision date
- October 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Traditional | 04/24/2019SE |
Questions and answers
When was R7 cleared by the FDA?
R7 (K130834) received a 510(k) decision of Substantially Equivalent on October 8, 2013, 196 days after the submission was received.
What is the product code of K130834?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.