510(k) K831245
K831245 is an FDA 510(k) premarket notification submitted by Ritter Co. for the device "TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO". The FDA issued a decision of Substantially Equivalent on October 19, 1983. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Ritter Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1983
- Date Received
- April 18, 1983
- 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