510(k) K080636
K080636 is an FDA 510(k) premarket notification submitted by Hubdic Co., Ltd. for the device "DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100". The FDA issued a decision of Substantially Equivalent on Feb 13, 2009. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Hubdic Co., Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2009
- Date Received
- Mar 6, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)