SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR


Device Classification Name

monitor, breathing frequency

510(k) Number K080922
Device Name SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
Applicant
SALTER LABS, DIVISION OF REGULATORY AFFAIRS
100 west sycamore rd.
arvin, 
CA 
93203

Applicant Contact duane kazal
Correspondent
SALTER LABS, DIVISION OF REGULATORY AFFAIRS
100 west sycamore rd.
arvin, 
CA 
93203

Correspodent Contact duane kazal
Regulation Number 868.2375
Classification Product Code
BZQ  
Date Received 04/01/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls