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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 K905586
Device Name RSVP RF-2000
Applicant
Tactilitics, Inc.
5595 Arapahoe
Boulder,  CO  80303
Applicant Contact KATHERINE HUTMAN
Correspondent
Tactilitics, Inc.
5595 Arapahoe
Boulder,  CO  80303
Correspondent Contact KATHERINE HUTMAN
Regulation Number880.2400
Classification Product Code
KMI  
Date Received12/06/1990
Decision Date 04/01/1991
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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