Stryker Aria Pneumatic System
FDA 510(k) K061725 · Stryker Instruments
510(k) numberK061725
Submission
- Device name
- Stryker Aria Pneumatic System
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- June 19, 2006
- Decision date
- October 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stryker Aria Pneumatic System cleared by the FDA?
Stryker Aria Pneumatic System (K061725) received a 510(k) decision of Substantially Equivalent on October 26, 2006, 129 days after the submission was received.
What is the product code of K061725?
The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.