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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Monitor, Bed Patient
510(k) Number K864827
Device Name RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR
Applicant
Tactilitics, Inc.
1021 Pearl St.
Boulder,  CO  80302
Applicant Contact GEORGE BEGGS
Correspondent
Tactilitics, Inc.
1021 Pearl St.
Boulder,  CO  80302
Correspondent Contact GEORGE BEGGS
Regulation Number880.2400
Classification Product Code
KMI  
Date Received12/09/1986
Decision Date 01/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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