510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073366Substantially Equivalent

Talking Clinical Electronic Thermometer, Models Dx6623b, Dt1031 and Dt1041

Shenzhen Dongdixin Technology Co., Ltd., Flintville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K073366 is the FDA 510(k) clearance record for TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041, a class II device, cleared for Shenzhen Dongdixin Technology Co., Ltd. on under FDA product code FLL (Continuous Measurement Thermometer). FDA's definition for product code FLL reads: "A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt...". FDA records list 26 510(k) clearances for Shenzhen Dongdixin Technology Co., Ltd., from to . As of , FDA records show no recalls naming K073366.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FLL Continuous Measurement Thermometer
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Applicant
Shenzhen Dongdixin Technology Co., Ltd. 340 Shady Grove Rd., Flintville TN
510(k) summary
Statement
Third party review
Yes

Clearances, product code FLL

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