510(k) K903222
K903222 is an FDA 510(k) premarket notification submitted by Biochem International, Inc. for the device "BIOCHEM 6100 NON-INVASIVE MONITOR". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Biochem International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1990
- Date Received
- July 23, 1990
- 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