510(k) K961223
K961223 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 10, 1996. Criticare Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1996
- Date Received
- March 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No