Monitor, Apnea, Home Use
The home-use apnea monitor is an anesthesiology device designed for home monitoring of patients, particularly infants, for cessation of breathing (apnea) to alert caregivers in the event of a respiratory emergency. It is classified as FDA Class 2 under regulation 868.2377 in the Anesthesiology specialty, requiring 510(k) clearance, and carries a life-sustaining flag. Product code NPF is functionally the same as product code FLS with the addition of a home-use indication.
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Basic Information
- Product Code
- NPF
- Device Class
- FDA class 2
- Regulation Number
- 868.2377
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
Same as the identification for product code FLS, just add home use
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.