Oximeter, Infrared, Sporting, Aviation
The Infrared Oximeter for Sporting and Aviation Activities (product code OCH) is a cardiovascular monitoring device solely intended for use during sporting and aviation activities to monitor heart rate during exercise, rather than for clinical diagnostic or treatment purposes. It uses infrared technology to detect physiological signals at the periphery. This device is FDA Class 2 under regulation 870.2700 in the Cardiovascular specialty; it falls under an enforcement discretion category (submission type 7) and is not subject to standard premarket notification requirements under the convenience kit/enforcement discretion framework. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCH
- Device Class
- FDA class 2
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 7
Device Characteristics
Definition
Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.