Syncra Tilt Option for Angio Diagnost 5
FDA 510(k) K940696 · Philips Medical Systems North America, Inc.
510(k) numberK940696
Submission
- Device name
- Syncra Tilt Option for Angio Diagnost 5
- Applicant
- Philips Medical Systems North America, Inc.
Shelton, CT, US - Received
- February 16, 1994
- Decision date
- March 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Syncra Tilt Option for Angio Diagnost 5 cleared by the FDA?
Syncra Tilt Option for Angio Diagnost 5 (K940696) received a 510(k) decision of Substantially Equivalent on March 16, 1994, 28 days after the submission was received.
What is the product code of K940696?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.