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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 K932902
Device Name MAGNUM
Applicant
SPS, INC.
6201 NORTH BELTLINE RD.
SUITE 115
IRVING,  TX  75063
Applicant Contact SPIEKERMAN
Correspondent
SPS, INC.
6201 NORTH BELTLINE RD.
SUITE 115
IRVING,  TX  75063
Correspondent Contact SPIEKERMAN
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/15/1993
Decision Date 05/10/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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