510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081603Substantially Equivalent

Digital Ballistocardiograph, Model Dgb 300

Heartforce Medical, Inc., Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081603 is the FDA 510(k) clearance record for DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300, a class II device, cleared for Heartforce Medical, Inc. on under FDA product code DXR (Ballistocardiograph). FDA records list one 510(k) clearance for Heartforce Medical, Inc. As of , FDA records show no recalls naming K081603.

Clearance record

Decision date
Received
(413 days to decision)
Product code
DXR Ballistocardiograph
Regulation
21 CFR 870.2320
Device class
Class II
Review panel
Cardiovascular
Applicant
Heartforce Medical, Inc. 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXR

Trailing 12 months

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

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