Last synced on 24 June 2022 at 11:05 pm

Abnormal Breath Sound Device

Page Type
Product Code
Definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Physical State
An electronic device
Technical Method
It is a hand-held electronic measurement device that utilizes an acoustic sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of breath sounds such as wheeze.
Target Area
Trachea
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1900
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1900 Diagnostic pulmonary-function interpretation calculator

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

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

Abnormal Breath Sound Device

Page Type
Product Code
Definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Physical State
An electronic device
Technical Method
It is a hand-held electronic measurement device that utilizes an acoustic sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of breath sounds such as wheeze.
Target Area
Trachea
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1900
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1900 Diagnostic pulmonary-function interpretation calculator

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

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