510(k) K983250
K983250 is an FDA 510(k) premarket notification submitted by Magnetic Resonance Equipment Corp. for the device "INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR". The FDA issued a decision of Substantially Equivalent on December 12, 1999. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. Magnetic Resonance Equipment Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1999
- Date Received
- September 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Blood-Pressure
- Device Class
- Class II
- Regulation Number
- 870.1110
- Review Panel
- CV
- Submission Type