GE Logiq 700
FDA 510(k) K001016 · GE Medical Systems
510(k) numberK001016
Submission
- Device name
- GE Logiq 700
- Applicant
- GE Medical Systems
Milwaukee, WI, US - Received
- March 29, 2000
- Decision date
- April 24, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GE Logiq 700 cleared by the FDA?
GE Logiq 700 (K001016) received a 510(k) decision of Substantially Equivalent on April 24, 2000, 26 days after the submission was received.
What is the product code of K001016?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.