510(k) K842519

BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 by Rna Medical Corp. — Product Code CHL

K842519 is an FDA 510(k) premarket notification submitted by Rna Medical Corp. for the device "BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Rna Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type