510(k) K832828
K832828 is an FDA 510(k) premarket notification submitted by Clinical Data Instruments, Inc. for the device "CENTURION CARDIAC DETECTOR". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code DRJ (System, Signal Isolation), a Class I device regulated under 21 CFR 870.2600. Clinical Data Instruments, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1984
- Date Received
- August 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Signal Isolation
- Device Class
- Class I
- Regulation Number
- 870.2600
- Review Panel
- CV
- Submission Type