Norodyn 8000 Semg System, ND-8000
FDA 510(k) K992439 · Myotronics-Noromed, Inc.
510(k) numberK992439
Submission
- Device name
- Norodyn 8000 Semg System, ND-8000
- Applicant
- Myotronics-Noromed, Inc.
Tukwila, WA, US - Received
- July 22, 1999
- Decision date
- August 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Norodyn 8000 Semg System, ND-8000 cleared by the FDA?
Norodyn 8000 Semg System, ND-8000 (K992439) received a 510(k) decision of Substantially Equivalent on August 13, 1999, 22 days after the submission was received.
What is the product code of K992439?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.