510(k) K941490
K941490 is an FDA 510(k) premarket notification submitted by Integrated Display Technology, Ltd. for the device "BLOOD PRESSURE METER MODEL NO. BPM888". The FDA issued a decision of Substantially Equivalent on November 29, 1994. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Integrated Display Technology, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1994
- Date Received
- March 28, 1994
- 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