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510(k) K921528

HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM by Hill-Rom, Inc. — Product Code IQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1992
Date Received
April 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Environmental Control, Powered
Device Class
Class II
Regulation Number
890.3725
Review Panel
PM
Submission Type

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  • K902664 — HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 (July 25, 1990)