Cleared Traditional

K930524 - END TIDAL CO2 OPTION B
(FDA 510(k) Clearance)

K930524 · Medical Data Electronics · Anesthesiology

Feb 1994

Decision

370d

Days

Class 2

Risk

K930524 is an FDA 510(k) clearance for the END TIDAL CO2 OPTION B. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK).

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on February 7, 1994, 370 days after receiving the submission on February 2, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K930524 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1993
Decision Date	February 07, 1994
Days to Decision	370 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement