FDA · official record K843285Substantially Equivalent

TRI-MED 610 CAPNOSTAT GAS ANALYZER

Name: TRI-MED 610 CAPNOSTAT GAS ANALYZER — FDA K843285
Creator: Tri-Med, Inc.
Keywords: TRI-MED 610 CAPNOSTAT GAS ANALYZER, TRI-MED 610 CAPNOSTAT GAS ANALYZER, K843285, CCK, FDA

United StatesCCKTri-Med, Inc.

Verified

Official record identity

FDA application number: K843285
Decision date: November 13, 1984
Published decision: Substantially Equivalent

Classification

Product code: CCK

Published parties

Applicant: Tri-Med, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1984-08-21
Review panel: Anesthesiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 868.1400

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.