OCH — Oximeter, Infrared, Sporting, Aviation Class II
FDA product code OCH covers "Oximeter, Infrared, Sporting, Aviation", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- OCH
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.