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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K873791
Device Name MODEL 500E INFANT MONITORING SYSTEM
Applicant
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Applicant Contact J. P LENZEN
Correspondent
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Correspondent Contact J. P LENZEN
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/17/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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