510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972603Substantially Equivalent

Electrocardiographs Models 110B, 120B and 310B

Dr. Lee Co., Ltd., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972603 is the FDA 510(k) clearance record for ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B, a class II device, cleared for Dr. Lee Co., Ltd. on under FDA product code DPS (Electrocardiograph). FDA records list 2 510(k) clearances for Dr. Lee Co., Ltd., from to . As of , FDA records show no recalls naming K972603.

Clearance record

Decision date
Received
(243 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Dr. Lee Co., Ltd. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code DPS

Trailing 12 months
6 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20260