Laryngoscope Kit
The Laryngoscope Kit is a convenience kit providing a laryngoscope and associated accessories used to visualize the larynx for intubation or airway assessment in anesthesia and emergency settings. It is classified as FDA Class 1 under regulation 21 CFR 868.5540 within the Anesthesiology medical specialty, the lowest risk tier subject to general controls only, and falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance without requiring a 510(k) submission. The product code is OGH. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- OGH
- Device Class
- FDA class 1
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.