510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974697Substantially Equivalent

Reusable Finger Sensor 3444

Bci Intl., Inc., Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974697 is the FDA 510(k) clearance record for REUSABLE FINGER SENSOR 3444, a class II device, cleared for Bci Intl., Inc. on under FDA product code DQH (Cardiograph, Apex (Vibrocardiograph)). FDA records list 20 510(k) clearances for Bci Intl., Inc., from to . As of , FDA records show no recalls naming K974697.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DQH Cardiograph, Apex (Vibrocardiograph)
Regulation
21 CFR 870.2310
Device class
Class II
Review panel
Cardiovascular
Applicant
Bci Intl., Inc. W238 N1650 Rockwood Dr., Waukesha WI
510(k) summary
Summary
Third party review
No

Clearances, product code DQH

Trailing 12 months

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

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