LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET— 510(k) K873435

Name: FDA 510(k) clearance K873435
Creator: U.S. Food and Drug Administration
Published: 1987-10-05

Substantially Equivalent

Level 1 Technologies, Inc.

FDA 510(k) clearance K873435 for LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET, Substantially Equivalent on 1987-10-05. Applicant: Level 1 Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Level 1 Technologies, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-26
Decision date: 1987-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MA, US

Download summary PDF View on FDA.gov ↗

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K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM1996-04-26
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K936223 — PRESSURE IRRIGATING SYSTEM1994-05-12
K911383 — HOTLINE FLUID WARMER1991-10-17

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.