Synergy Iom System
FDA 510(k) K984052 · Oxford Instruments Medical Systems
510(k) numberK984052
Submission
- Device name
- Synergy Iom System
- Applicant
- Oxford Instruments Medical Systems
Crofton, MD, US - Received
- November 13, 1998
- Decision date
- May 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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Questions and answers
When was Synergy Iom System cleared by the FDA?
Synergy Iom System (K984052) received a 510(k) decision of Substantially Equivalent on May 17, 1999, 185 days after the submission was received.
What is the product code of K984052?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.