Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories
FDA 510(k) K061907 · GE Healthcare
510(k) numberK061907
Submission
- Device name
- Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories
- Applicant
- GE Healthcare
Needham, MA, US - Received
- July 5, 2006
- Decision date
- March 27, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLW – Index-Generating Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
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Questions and answers
When was Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories cleared by the FDA?
Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories (K061907) received a 510(k) decision of Substantially Equivalent on March 27, 2008, 631 days after the submission was received.
What is the product code of K061907?
The FDA product code is OLW – Index-Generating Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.