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Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.5640
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5640 Medicinal nonventilatory nebulizer (atomizer)

§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).

(a) Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.5640
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5640 Medicinal nonventilatory nebulizer (atomizer)

§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).

(a) Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]