510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K871149Substantially Equivalent

Drm 2300 Plethysmographic Cardiotachometer

Iontec Corp., Hammond LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871149 is the FDA 510(k) clearance record for DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER, a class II device, cleared for Iontec Corp. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list one 510(k) clearance for Iontec Corp. As of , FDA records show no recalls naming K871149.

Clearance record

Decision date
Received
(74 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Iontec Corp. 182 Substation Rd., Hammond LA
Third party review
No

Clearances, product code DRT

Trailing 12 months
4 clearances under product code DRT 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 DRT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260