510(k) K942649
K942649 is an FDA 510(k) premarket notification submitted by Rud Riester GmbH & CO KG for the device "MINIMUS I; MINIMUS III, SANAPHON". 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. Rud Riester GmbH & CO KG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1994
- Date Received
- May 31, 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