510(k) K800111
K800111 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "CO2 CONTENT". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code CIL (Cresol Red Colorimetry, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. American Monitor Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1980
- Date Received
- January 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cresol Red Colorimetry, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type