Olympic Medical Lectromed Cerebral Function Monitor System
FDA 510(k) K983229 · Olympic Medical Corp.
510(k) numberK983229
Submission
- Device name
- Olympic Medical Lectromed Cerebral Function Monitor System
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- September 15, 1998
- Decision date
- March 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMA – Amplitude-Integrated Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
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| K955357 | Olympic Smart Scale Model 50/50RAFRW · Traditional | 01/30/1996SE |
| K954434 | Olympic Infant ThermometerFLL · Traditional | 12/20/1995SE |
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Questions and answers
When was Olympic Medical Lectromed Cerebral Function Monitor System cleared by the FDA?
Olympic Medical Lectromed Cerebral Function Monitor System (K983229) received a 510(k) decision of Substantially Equivalent on March 23, 1999, 189 days after the submission was received.
What is the product code of K983229?
The FDA product code is OMA – Amplitude-Integrated Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.