FDA · official record K870501Substantially Equivalent

THE EQUALIZER AIRWAY DEVICE

Name: THE EQUALIZER AIRWAY DEVICE — FDA K870501
Creator: Sleep Renewal, Inc.
Keywords: THE EQUALIZER AIRWAY DEVICE, THE EQUALIZER AIRWAY DEVICE, K870501, LQZ, FDA

United StatesLQZSleep Renewal, Inc.

Verified

Official record identity

FDA application number: K870501
Decision date: March 04, 1987
Published decision: Substantially Equivalent

Classification

Product code: LQZ

Published parties

Applicant: Sleep Renewal, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1987-02-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5570

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.