Ultrasound Scanner Flex Focus, Model 1202
FDA 510(k) K081154 · B-K Medical Aps
510(k) numberK081154
Submission
- Device name
- Ultrasound Scanner Flex Focus, Model 1202
- Applicant
- B-K Medical Aps
Herlev, DK - Received
- April 23, 2008
- Decision date
- May 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ultrasound Scanner Flex Focus, Model 1202 cleared by the FDA?
Ultrasound Scanner Flex Focus, Model 1202 (K081154) received a 510(k) decision of Substantially Equivalent on May 23, 2008, 30 days after the submission was received.
What is the product code of K081154?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.