SALTER LABS MODEL #4009 SAMPLE LINES

About This 510(k) Submission

K894350 is an FDA 510(k) clearance for the SALTER LABS MODEL #4009 SAMPLE LINES, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on October 3, 1989, 81 days after receiving the submission on July 14, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.