ALGO 3I NEWBORN HEARING SCREENER


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K030823
Device Name ALGO 3I NEWBORN HEARING SCREENER
Applicant
NATUS MEDICAL, INC.
1501 industrial rd.
san carlos, 
CA 
94070

Applicant Contact ron kohlhardt
Correspondent
NATUS MEDICAL, INC.
1501 industrial rd.
san carlos, 
CA 
94070

Correspodent Contact ron kohlhardt
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 03/14/2003
Decision Date 04/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls