510(k) K921528

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

K921528 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 1992. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

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