MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY— 510(k) K113215

Name: FDA 510(k) clearance K113215
Creator: U.S. Food and Drug Administration
Published: 2012-05-14

Substantially Equivalent

Nonin Medical, Inc.

FDA 510(k) clearance K113215 for MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY, Substantially Equivalent on 2012-05-14. Applicant: Nonin Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nonin Medical, Inc.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2011-11-01
Decision date: 2012-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUD

view all

K254129 — Spectrum-22026-05-22
K243324 — Masimo O3 Regional Oximeter2025-07-17
K250519 — Lap.Ox Laparoscopic Tissue Oximeter2025-06-26
K240596 — Cerebral Autoregulation Index (CAI) Algorithm2024-10-16
K241393 — ODI-Tech2024-08-30

More clearances from Nonin Medical, Inc.

view all

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.