5CM Small Parts Scanner
FDA 510(k) K810914 · Smithkline Diagnostics, Inc.
510(k) numberK810914
Submission
- Device name
- 5CM Small Parts Scanner
- Applicant
- Smithkline Diagnostics, Inc.
Walker, MI, US - Received
- April 6, 1981
- Decision date
- May 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 5CM Small Parts Scanner cleared by the FDA?
5CM Small Parts Scanner (K810914) received a 510(k) decision of Substantially Equivalent on May 8, 1981, 32 days after the submission was received.
What is the product code of K810914?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.