510(k) K130207
K130207 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare, Ltd. for the device "SPACELABS HEALTHCARE CARDIOEXPRESS". The FDA issued a decision of Substantially Equivalent on July 23, 2013. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Spacelabs Healthcare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2013
- Date Received
- January 28, 2013
- 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