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510(k) K150457

AlfaSight 9000 Thermographic System by Alfa Thermodiagnostics, Inc. — Product Code LHQ

K150457 is an FDA 510(k) premarket notification submitted by Alfa Thermodiagnostics, Inc. for the device "AlfaSight 9000 Thermographic System". The FDA issued a decision of Substantially Equivalent on April 10, 2015. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2015
Date Received
February 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type

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FDA data resources