510(k) K173895
K173895 is an FDA 510(k) premarket notification submitted by I.E.M. Industrielle Entwicklung And Medizintechnik for the device "Tel-O-Graph". The FDA issued a decision of Substantially Equivalent on May 16, 2019. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2019
- Date Received
- Dec 21, 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
- 510(k)