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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 K770695
Device Name MONITOR, BED, TECHNOLICS
Applicant
Technolics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Technolics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2400
Classification Product Code
KMI  
Date Received04/15/1977
Decision Date 07/14/1977
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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