510(k) K160092
K160092 is an FDA 510(k) premarket notification submitted by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. for the device "Digital Electrocardiograph". The FDA issued a decision of Substantially Equivalent on Feb 12, 2016. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Shenzhen Biocare Bio-Medical Equipment Co., Ltd. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 2016
- Date Received
- Jan 15, 2016
- Clearance Type
- Special
- 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
- 510(k)