Cleared Traditional

K971348 - FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
(FDA 510(k) Clearance)

K971348 · Green Field Medical Sourcing, Inc. · Anesthesiology device

Feb 1998

Decision

323d

Days

Class 2

Risk

K971348 is an FDA 510(k) clearance for the FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM. This device is classified as a Airway, Esophageal (obturator) (Class II - Special Controls, product code CAO).

Submitted by Green Field Medical Sourcing, Inc. (Shrewsbury, US). The FDA issued a Cleared decision on February 27, 1998, 323 days after receiving the submission on April 10, 1997.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5650.

Submission Details

510(k) Number	K971348 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 10, 1997
Decision Date	February 27, 1998
Days to Decision	323 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement