Amx-Iii
FDA 510(k) K802047 · General Electric Co.
510(k) numberK802047
Submission
- Device name
- Amx-Iii
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- August 25, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
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Questions and answers
When was Amx-Iii cleared by the FDA?
Amx-Iii (K802047) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 59 days after the submission was received.
What is the product code of K802047?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.