ALGO 5 NEWBORN HEARING SCREENER


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K073665
Device Name ALGO 5 NEWBORN HEARING SCREENER
Applicant
NATUS MEDICAL, INC.
1501 industrial rd.
san carlos, 
CA 
94070

Applicant Contact tom boles
Correspondent
NATUS MEDICAL, INC.
1501 industrial rd.
san carlos, 
CA 
94070

Correspodent Contact tom boles
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 12/26/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No