Micro Targeting Electrode
FDA 510(k) K033173 · FHC, Inc.
510(k) numberK033173
Submission
- Device name
- Micro Targeting Electrode
- Applicant
- FHC, Inc.
Bowdoinham, ME, US - Received
- October 1, 2003
- Decision date
- March 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Micro Targeting Electrode cleared by the FDA?
Micro Targeting Electrode (K033173) received a 510(k) decision of Substantially Equivalent on March 24, 2004, 175 days after the submission was received.
What is the product code of K033173?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.