OXYCHEK OXYGEN ANALYZER— 510(k) K942593

Name: FDA 510(k) clearance K942593
Creator: U.S. Food and Drug Administration
Published: 1995-05-03

Substantially Equivalent

Nidek Medical Products, Inc.

FDA 510(k) clearance K942593 for OXYCHEK OXYGEN ANALYZER, Substantially Equivalent on 1995-05-03. Applicant: Nidek Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Nidek Medical Products, Inc.
Product code: Code CCL
Device class: Class 2
Regulation: 21 CFR 868.1720
Advisory panel: Anesthesiology
Date received: 1994-06-01
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCL

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K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)2026-07-30
K251245 — OxyMinder Pro (10310)2025-08-11
K250002 — Smart Check O2 (MA0236)2025-04-24
K221734 — Maxtec MaxO2 ME+p2023-04-01
K213933 — Percent Oxygen Sensors2022-08-19

More clearances from Nidek Medical Products, Inc.

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K192693 — Nuvo Nano Portable Oxygen Concentrator2020-05-07
K123738 — MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD2013-02-28
K093308 — MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD2010-01-14
K082566 — MARK 5 NUVO LITE OCSI AND STD2008-12-03
K040892 — MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 9052004-04-29

Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.