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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 K802046
Device Name PDS MODEL 3000 ADULT RESPIRATION MODULE
Applicant
General Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
General Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received08/25/1980
Decision Date 09/16/1980
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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