510(k) K014262
K014262 is an FDA 510(k) premarket notification submitted by Cosmed Srl for the device "COSMED QUARK C12/QUARK T12". The FDA issued a decision of Substantially Equivalent on March 26, 2002. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cosmed Srl has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2002
- Date Received
- December 27, 2001
- 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