Ultra Imager 2000
FDA 510(k) K834282 · Honeywell, Inc.
510(k) numberK834282
Submission
- Device name
- Ultra Imager 2000
- Applicant
- Honeywell, Inc.
- Received
- November 21, 1983
- Decision date
- April 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ultra Imager 2000 cleared by the FDA?
Ultra Imager 2000 (K834282) received a 510(k) decision of Substantially Equivalent on April 23, 1984, 154 days after the submission was received.
What is the product code of K834282?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.