510(k) K841080
K841080 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON RA-1000 SYS CO2". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code CHS (Coulometric Method, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1984
- Date Received
- March 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coulometric Method, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type