510(k) K823934
K823934 is an FDA 510(k) premarket notification submitted by Odam for the device "CARIEL F12". The FDA issued a decision of Substantially Equivalent on December 16, 1983. The device falls under product code DYC (Vectorcardiograph), a Class II device regulated under 21 CFR 870.2400. Odam has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1983
- Date Received
- December 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vectorcardiograph
- Device Class
- Class II
- Regulation Number
- 870.2400
- Review Panel
- CV
- Submission Type