Sage 7
FDA 510(k) K984167 · GE Medical Systems
510(k) numberK984167
Submission
- Device name
- Sage 7
- Applicant
- GE Medical Systems
Waukesha, WI, US - Received
- November 20, 1998
- Decision date
- January 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sage 7 cleared by the FDA?
Sage 7 (K984167) received a 510(k) decision of Substantially Equivalent on January 12, 1999, 53 days after the submission was received.
What is the product code of K984167?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.