NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116— 510(k) K013133

Name: FDA 510(k) clearance K013133
Creator: U.S. Food and Drug Administration
Published: 2001-11-13

Substantially Equivalent

Nordix, Inc.

FDA 510(k) clearance K013133 for NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116, Substantially Equivalent on 2001-11-13. Applicant: Nordix, Inc.. Device class: 1.

Clearance details

Applicant: Nordix, Inc.
Product code: Code MOQ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 2001-09-19
Decision date: 2001-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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Recent devices under product code MOQ

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Adverse events under product code MOQ

product code MOQ

Malfunction: 1,643
Total: 1,643

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.