510(k) K982342
K982342 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP MPS SELECT PORTABLE MONITOR". The FDA issued a decision of Substantially Equivalent on August 14, 1998. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Critikon Company, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1998
- Date Received
- July 6, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type