510(k) K896930
K896930 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CARDIAC OUTPUT COMPUTER, MODEL COM-3". The FDA issued a decision of Substantially Equivalent on Jul 3, 1990. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 3, 1990
- Date Received
- Dec 11, 1989
- 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
- 510(k)