Cleared Traditional

SALTER LABS DISPOSABLE NIPPLE AND NUT

K912174 · Salter Labs · Anesthesiology
Jul 1991
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K912174 is an FDA 510(k) clearance for the SALTER LABS DISPOSABLE NIPPLE AND NUT, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 24, 1991, 69 days after receiving the submission on May 16, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number K912174 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1991
Decision Date July 24, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAN — Regulator, Pressure, Gas Cylinder
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2700

Similar Devices — CAN Regulator, Pressure, Gas Cylinder

All 54
MR Conditional CGA 870
K162811 · Essex Industries, Inc. · Mar 2017
PORTABLE OXYGEN UNIT SCA900
K080243 · San Cheong Co. , Ltd. · Apr 2009
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
K060265 · Remcore, Inc. · Oct 2006
CYL-FIL OXYGEN SYSTEM
K061785 · Responsive Respiratory, Inc. · Sep 2006
OXYGEN REGULATOR
K950777 · Mada Medical Products, Inc. · Apr 1995
VANGUARD SERIES GAS REGULATORS
K942751 · Buckman Co., Inc. · Feb 1995

More from Salter Labs

View all
Salter Labs Bubble Humidifier
K161719 · BTT · Sep 2017
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
K151874 · MNR · Apr 2016
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506 · NFB · Mar 2016
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
K151421 · CCK · Mar 2016
CPAP Cannulaide
K143700 · BZD · Aug 2015