Last synced on 25 November 2022 at 11:04 pm

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

Page Type
Product Code
Definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Regulation Medical Specialty
General Hospital
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.5045
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.5045 Medical recirculating air cleaner

§ 880.5045 Medical recirculating air cleaner.

(a) Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

(b) Classification. Class II (performance standards).

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

Page Type
Product Code
Definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Regulation Medical Specialty
General Hospital
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
880.5045
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.5045 Medical recirculating air cleaner

§ 880.5045 Medical recirculating air cleaner.

(a) Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

(b) Classification. Class II (performance standards).