510(k) K933404
K933404 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "CRITIKON CENTRAL STATIN MONITOR". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Critikon Company, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1994
- Date Received
- July 12, 1993
- 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