FDA.reportPublic FDA data

510(k) K140097

Device
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
510(k) number
K140097
Product code
CBH  
Decision
Substantially Equivalent (SESE)
Decision date
2014-09-24
Date received
2014-01-14
Regulation
868.5770
Classification name
Device, Fixation, Tracheal Tube
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSHUA MEINKE
Address
8000 Katherine Blvd. Brecksville OH US 44141 44141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.1997-01-28
K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.1995-06-14
K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.1995-04-24
K950930TRACHE-TITEThe Varner Group, Inc.1995-03-22
K950318FLEX BLUEKing Systems Corp.1995-02-13
K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products Corp.1994-06-30
K934288HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BARNeo-Tech, Inc.1994-06-09
K942016TRACH TIE, VENTILATOR TUBING HOLDERGarrett Medical Products1994-05-24
K941384TRAKEEZErgomed, Inc.1994-04-19
K940448NETOH ENDOTRACHEAL TUBE HOLDERMedical Accessory Services, Inc.1994-02-22
K936094PREPARE LOCKPrepare, Inc.1994-02-03
K935171STABILTRACHB&B Medical Technologies, Inc.1993-12-02
K933420BREATHING TUBE SUPPORTBlake Medical, Inc.1993-10-13
K933781ANTI-DISCONNECTION MECHANISMHammer-Plane, Inc.1993-09-22
K925386ADHESIVE E.T. TAPEB&B Medical Technologies, Inc.1993-04-19

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases