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
K123658Substantially Equivalent

Biomodule 3-M1

Zephyr Technology Corporation, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123658 is the FDA 510(k) clearance record for BIOMODULE 3-M1, a class II device, cleared for Zephyr Technology Corporation on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 4 510(k) clearances for Zephyr Technology Corporation, from to . As of , FDA records show no recalls naming K123658.

Clearance record

Decision date
Received
(147 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Zephyr Technology Corporation 1151 Hope St., Stamford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

FDA records show no clearances under product code DRX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRX, 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