Pureimage Ultrasound Transmission Gel
FDA 510(k) K120156 · Medline
510(k) numberK120156
Submission
- Device name
- Pureimage Ultrasound Transmission Gel
- Applicant
- Medline
Mundelein, IL, US - Received
- January 18, 2012
- Decision date
- February 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Pureimage Ultrasound Transmission Gel cleared by the FDA?
Pureimage Ultrasound Transmission Gel (K120156) received a 510(k) decision of Substantially Equivalent on February 8, 2012, 21 days after the submission was received.
What is the product code of K120156?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.