Sleep Stager
FDA 510(k) K850541 · Oxford Medilog, Inc.
510(k) numberK850541
Submission
- Device name
- Sleep Stager
- Applicant
- Oxford Medilog, Inc.
Clearwater, FL, US - Received
- February 11, 1985
- Decision date
- August 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- OLT – Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
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Questions and answers
When was Sleep Stager cleared by the FDA?
Sleep Stager (K850541) received a 510(k) decision of Substantially Equivalent on August 2, 1985, 172 days after the submission was received.
What is the product code of K850541?
The FDA product code is OLT – Non-Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.