510(k) K853018
K853018 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "MODEL 3000 OPTICATH COMPUTER". The FDA issued a decision of Substantially Equivalent on Jan 13, 1986. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Oximetrix, Inc. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 1986
- Date Received
- Jul 17, 1985
- 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)