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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K923788
Device Name SPACE LABS MODEL 90560
Applicant
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Applicant Contact RAYMOND W GIFFORD
Correspondent
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Correspondent Contact RAYMOND W GIFFORD
Classification Product Code
LOS
Date Received07/28/1992
Decision Date 12/06/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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