FDA · official record K991874Substantially Equivalent

EMS SURFACE MOUNT SCALER

Name: EMS SURFACE MOUNT SCALER — FDA K991874
Creator: (Ems Sa) Electro Medical Systems
Keywords: EMS SURFACE MOUNT SCALER, EMS SURFACE MOUNT SCALER, K991874, ELC, FDA

United StatesELC(Ems Sa) Electro Medical Systems

Verified

Official record identity

FDA application number: K991874
Decision date: July 30, 1999
Published decision: Substantially Equivalent

Classification

Product code: ELC

Published parties

Applicant: (Ems Sa) Electro Medical Systems

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-06-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4850

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.