510(k) K172498
K172498 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y". The FDA issued a decision of Substantially Equivalent on October 13, 2017. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Intellectual Property GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2017
- Date Received
- August 18, 2017
- 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