OGLClass II
Oxygen Administration Kit
21 CFR 868.5655 / Anesthesiology
OGL is the FDA product code for Oxygen Administration Kit, a class II device type, regulated under 21 CFR 868.5655. FDA's definition for this code reads: "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))...". As of , FDA records hold no 510(k) clearances under this code and one recall.
Classification record
- Product code
- OGL
- Device name
- Oxygen Administration Kit
- FDA 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.
- Regulation
- 21 CFR 868.5655
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- FDA code 7
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 1
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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