510(k) K012059
K012059 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "8100/8500 VITAL SIGNS MONITOR". The FDA issued a decision of Substantially Equivalent on Aug 1, 2001. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Criticare Systems, Inc. has 21 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 2001
- Date Received
- Jul 2, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)