510(k) K171517
K171517 is an FDA 510(k) premarket notification submitted by Biocare Bio-Medical Equipment Co., Ltd. for the device "Digital Electrocardiograph". The FDA issued a decision of Substantially Equivalent on Jan 11, 2018. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2018
- Date Received
- May 24, 2017
- 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)