510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081233Substantially Equivalent

T-Stat 303 Ischemia Monitoring System

Spectros Corporation, Highlands Ranch CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081233 is the FDA 510(k) clearance record for T-STAT 303 ISCHEMIA MONITORING SYSTEM, a class II device, cleared for Spectros Corporation on under FDA product code MUD (Oximeter, Tissue Saturation). FDA records list 3 510(k) clearances for Spectros Corporation, from to . As of , FDA records show no recalls naming K081233.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MUD Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectros Corporation 9433 S. Morning Glory Ln., Highlands Ranch CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUD

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