EMM Ultrasonic Transducer Cover
FDA 510(k) K211969 · Exact Medical Manufacturing
510(k) numberK211969
Submission
- Device name
- EMM Ultrasonic Transducer Cover
- Applicant
- Exact Medical Manufacturing
Lancaster, NY, US - Received
- June 24, 2021
- Decision date
- August 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was EMM Ultrasonic Transducer Cover cleared by the FDA?
EMM Ultrasonic Transducer Cover (K211969) received a 510(k) decision of Substantially Equivalent on August 13, 2021, 50 days after the submission was received.
What is the product code of K211969?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.