Harris Model 2000
FDA 510(k) K921906 · Harris Mfg. Co.
510(k) numberK921906
Submission
- Device name
- Harris Model 2000
- Applicant
- Harris Mfg. Co.
Trenton, NJ, US - Received
- April 21, 1992
- Decision date
- November 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Harris Model 2000 cleared by the FDA?
Harris Model 2000 (K921906) received a 510(k) decision of Substantially Equivalent on November 2, 1992, 195 days after the submission was received.
What is the product code of K921906?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.