510(k) K921309
K921309 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "MODEL 508 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Criticare Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1993
- Date Received
- March 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type