510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K894234Substantially Equivalent

Sensocor Tm R-Test 24Oxl

Sensocor, Pompano Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894234 is the FDA 510(k) clearance record for SENSOCOR TM R-TEST 24OXL, a class II device, cleared for Sensocor on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list one 510(k) clearance for Sensocor. As of , FDA records show no recalls naming K894234.

Clearance record

Decision date
Received
(44 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Sensocor 750 E. Sample Rd., Pompano Beach FL
Third party review
No

Clearances, product code DXG

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