Eocene System
FDA 510(k) K090712 · Infopia Co, Ltd.
510(k) numberK090712
Submission
- Device name
- Eocene System
- Applicant
- Infopia Co, Ltd.
Great Neck, NY, US - Received
- March 18, 2009
- Decision date
- October 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Eocene System cleared by the FDA?
Eocene System (K090712) received a 510(k) decision of Substantially Equivalent on October 2, 2009, 198 days after the submission was received.
What is the product code of K090712?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.