Sonar-Aid(R) Ultrasound Standoff Pad
FDA 510(k) K874943 · Geistlich-Pharma
510(k) numberK874943
Submission
- Device name
- Sonar-Aid(R) Ultrasound Standoff Pad
- Applicant
- Geistlich-Pharma
Washington, DC, US - Received
- December 2, 1987
- Decision date
- July 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Sonar-Aid(R) Ultrasound Standoff Pad cleared by the FDA?
Sonar-Aid(R) Ultrasound Standoff Pad (K874943) received a 510(k) decision of Substantially Equivalent on July 25, 1988, 236 days after the submission was received.
What is the product code of K874943?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.