510(k) K830843
K830843 is an FDA 510(k) premarket notification submitted by Rna Medical Corp. for the device "BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code JKT (Gas Chromatograph, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220. Rna Medical Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1983
- Date Received
- March 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas Chromatograph, Carbon-Monoxide
- Device Class
- Class I
- Regulation Number
- 862.3220
- Review Panel
- TX
- Submission Type