Cleared Traditional

K770015 - NOSECLIP FOR RESP. CARE & PULMON. FUNC. (FDA 510(k) Clearance)

Mar 1977
Decision
72d
Days
Class 1
Risk

K770015 is an FDA 510(k) clearance for the NOSECLIP FOR RESP. CARE & PULMON. FUNC.. This device is classified as a Clip, Nose (Class I - General Controls, product code BXJ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 16, 1977, 72 days after receiving the submission on January 3, 1977.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6225.

Submission Details

510(k) Number K770015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1977
Decision Date March 16, 1977
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BXJ — Clip, Nose
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.6225