510(k) K030535
K030535 is an FDA 510(k) premarket notification submitted by Qrs Diagnostic, LLC for the device "EKGCARD SYSTEM". The FDA issued a decision of Substantially Equivalent on June 11, 2003. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Qrs Diagnostic, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2003
- Date Received
- February 20, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type