510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971956Substantially Equivalent

Crt2000 Thermographic System

Werner Eidam Medizin-Technologie GmbH, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971956 is the FDA 510(k) clearance record for CRT2000 THERMOGRAPHIC SYSTEM, a class I device, cleared for Werner Eidam Medizin-Technologie GmbH on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list one 510(k) clearance for Werner Eidam Medizin-Technologie GmbH. As of , FDA records show no recalls naming K971956.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Werner Eidam Medizin-Technologie GmbH 1900 K St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code LHQ

Trailing 12 months
1 clearance under product code LHQ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260