510(k) K911645
K911645 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "NGM NIBP MODULE". The FDA issued a decision of Substantially Equivalent on March 4, 1992. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Datex Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1992
- Date Received
- April 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type