inforMED
CAZClass II

Anesthesia Conduction Kit

Anesthesiology · 21 CFR 868.5140

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events5,152All time
Recalls220All time
Registered firms353Currently listed
510(k) clearances155All time

Recalls

220 recall events for this product code

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