OGH · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.5540
Classification
FDA Product Code
OGH
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 868.5540
Review panel
AN
Medical specialty
Anesthesiology
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.