Duo-Max Blood Pressure & Glucose Monitor HMF-100
FDA 510(k) K080636 · Hubdic Co., Ltd.
510(k) numberK080636
Submission
- Device name
- Duo-Max Blood Pressure & Glucose Monitor HMF-100
- Applicant
- Hubdic Co., Ltd.
Great Neck, NY, US - Received
- March 6, 2008
- Decision date
- February 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Duo-Max Blood Pressure & Glucose Monitor HMF-100 cleared by the FDA?
Duo-Max Blood Pressure & Glucose Monitor HMF-100 (K080636) received a 510(k) decision of Substantially Equivalent on February 13, 2009, 344 days after the submission was received.
What is the product code of K080636?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.