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
K852652Substantially Equivalent

Omnigraph 4000(Electrocardiograph)

Telemed Div., Hoffman Estates IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852652 is the FDA 510(k) clearance record for OMNIGRAPH 4000(ELECTROCARDIOGRAPH), a class II device, cleared for Telemed Div. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 2 510(k) clearances for Telemed Div., from to . As of , FDA records show no recalls naming K852652.

Clearance record

Decision date
Received
(151 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Telemed Div. 2345 Pembroke Ave., Hoffman Estates IL
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, 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 20261
October 20260