510(k) K002822
K002822 is an FDA 510(k) premarket notification submitted by Medical Positioning, Inc. for the device "VERTEX SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 2001. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Medical Positioning, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2001
- Date Received
- September 11, 2000
- 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