510(k) K861543
K861543 is an FDA 510(k) premarket notification submitted by Columbus Instruments Intl. Corp. for the device "CARDIOMAX-II". The FDA issued a decision of Substantially Equivalent on March 10, 1987. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Columbus Instruments Intl. Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1987
- Date Received
- April 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type