Cleared Traditional

K771431 - ARTIFICIAL K-NOSE BREATHAID
(FDA 510(k) Clearance)

K771431 · Terumo America, Inc. · Cardiovascular device
Sep 1977
Decision
58d
Days
—
Risk

K771431 is an FDA 510(k) clearance for the ARTIFICIAL K-NOSE BREATHAID..

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977, 58 days after receiving the submission on August 1, 1977.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K771431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date September 28, 1977
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code —
Device Class —