7200 Ma Echo-Ophthalmoscope
FDA 510(k) K800100 · Kt Medical, Inc.
510(k) numberK800100
Submission
- Device name
- 7200 Ma Echo-Ophthalmoscope
- Applicant
- Kt Medical, Inc.
Mchenry, IL, US - Received
- January 14, 1980
- Decision date
- February 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 7200 Ma Echo-Ophthalmoscope cleared by the FDA?
7200 Ma Echo-Ophthalmoscope (K800100) received a 510(k) decision of Substantially Equivalent on February 21, 1980, 38 days after the submission was received.
What is the product code of K800100?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.