510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K002514Substantially Equivalent

Cadhealth System, Model Chp-001

Caduceus Health Care, Ltd., Halifax Ns, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002514 is the FDA 510(k) clearance record for CADHEALTH SYSTEM, MODEL CHP-001, a class II device, cleared for Caduceus Health Care , Ltd. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list one 510(k) clearance for Caduceus Health Care , Ltd. As of , FDA records show no recalls naming K002514.

Clearance record

Decision date
Received
(289 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
Caduceus Health Care , Ltd. 1809 Barrington St. Suite 708, Halifax Ns, CA
510(k) summary
Summary
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260