KC 100 M
FDA 510(k) K834285 · Elscint, Inc.
510(k) numberK834285
Submission
- Device name
- KC 100 M
- Applicant
- Elscint, Inc.
Mchenry, IL, US - Received
- November 15, 1983
- Decision date
- February 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K970005 | Gyrex 2T-PRESTIGELNI · Traditional | 03/28/1997SE |
Questions and answers
When was KC 100 M cleared by the FDA?
KC 100 M (K834285) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 94 days after the submission was received.
What is the product code of K834285?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.