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510(k) K971198

BABYTHERM 8004 BABYTHERM 8010 by Drager, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1997
Date Received
March 31, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

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  • K950853 — OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS (November 5, 1996)

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