Cleared Traditional

SALTER LABS MODEL #1015

K903539 · Salter Labs · Anesthesiology
Dec 1990
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K903539 is an FDA 510(k) clearance for the SALTER LABS MODEL #1015, a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on December 17, 1990, 132 days after receiving the submission on August 7, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number K903539 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1990
Decision Date December 17, 1990
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBH — Device, Fixation, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5770

Similar Devices — CBH Device, Fixation, Tracheal Tube

All 46
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · Applied Medical Technology, Inc. · Sep 2014
DALE ENDOTRACHEAL TUBE HOLDER 270/280
K964399 · Dale Medical Products, Inc. · Jan 1997
HCI TUBE STABILIZER
K942529 · Health Care Contracts, Inc. · Jun 1995
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
K951491 · Dale Medical Products, Inc. · Apr 1995
TRACHE-TITE
K950930 · The Varner Group, Inc. · Mar 1995
FLEX BLUE
K950318 · King Systems Corp. · 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