510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894627Substantially Equivalent

Bt-338N Electronic Clinical Thermometer

Integrated Display Technology, Ltd., Kowloon, Hong Kong, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894627 is the FDA 510(k) clearance record for BT-338N ELECTRONIC CLINICAL THERMOMETER, a class II device, cleared for Integrated Display Technology, Ltd. on under FDA product code FCI (Punch, Biopsy). FDA records list 5 510(k) clearances for Integrated Display Technology, Ltd., from to . As of , FDA records show no recalls naming K894627.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FCI Punch, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Integrated Display Technology, Ltd. 41, Man Yue St., Kaiser Estate, Kowloon, Hong Kong, HK
Third party review
No

Clearances, product code FCI

Trailing 12 months

FDA records hold no clearances under product code FCI in the trailing twelve months.

FDA records show no clearances under product code FCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260