Phasis Electromyograph
FDA 510(k) K922488 · Biosound, Inc.
510(k) numberK922488
Submission
- Device name
- Phasis Electromyograph
- Applicant
- Biosound, Inc.
San Jose, CA, US - Received
- May 27, 1992
- Decision date
- March 2, 1993
- 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 Phasis Electromyograph cleared by the FDA?
Phasis Electromyograph (K922488) received a 510(k) decision of Substantially Equivalent on March 2, 1993, 279 days after the submission was received.
What is the product code of K922488?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.