CAZ

Anesthesia Conduction Kit

Product code
CAZ
Device name
Anesthesia Conduction Kit
Device class
Class 2
21 CFR
21 CFR 868.5140
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
155

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: CAZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).