510(k) K033513
K033513 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "EASI ECG ALGORITHM". The FDA issued a decision of Substantially Equivalent on January 15, 2004. The device falls under product code DRW (Adaptor, Lead Switching, Electrocardiograph), a Class II device regulated under 21 CFR 870.2350. Philips Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2004
- Date Received
- November 6, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Lead Switching, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2350
- Review Panel
- CV
- Submission Type