FLOW-DIRECTED PEDIATRIC THERMODIL- CATH— 510(k) K843410

Substantially Equivalent

Andover Medical, Inc.

FDA 510(k) clearance K843410 for FLOW-DIRECTED PEDIATRIC THERMODIL- CATH, Substantially Equivalent on 1984-11-20. Applicant: Andover Medical, Inc.. Device class: 2.

Clearance details

Applicant
Andover Medical, Inc.
Product code
Code KRB
Device class
Class 2
Regulation
21 CFR 870.1915
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lawrence, MA, US
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