510(k) K961063
K961063 is an FDA 510(k) premarket notification submitted by Datex Medical Instrumentation, Inc. for the device "AS/3 CARDIAC OUTPUT & SVO2 MODULE". The FDA issued a decision of Substantially Equivalent on May 31, 1996. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Datex Medical Instrumentation, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 1996
- Date Received
- March 18, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type