510(k) K093872
K093872 is an FDA 510(k) premarket notification submitted by Beijing Choice Electronic Technololgy Co., Ltd. for the device "HANDHELD ECG MONITOR, MODEL MD100". The FDA issued a decision of Substantially Equivalent on March 31, 2010. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Beijing Choice Electronic Technololgy Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2010
- Date Received
- December 17, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type