510(k) K771587

Device
INSTANT AIR
Applicant
Hyde, Vernon E., D.D.S.
510(k) number
K771587
Product code
BWC
Decision
Substantially Equivalent (SESE)
Decision date
1977-09-02
Date received
1977-08-18
Regulation
868.5090
Classification name
Needle, Emergency Airway
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BWC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200190ScalpelCricVBM Medizintechnik GmbH2020-10-30
K160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter SetCook Incorporated2017-02-17
K153761Emergency Transtracheal Airway CatheterCook Incorporated2016-09-22
K130405RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SETTeleflex Medical2013-11-06
K050166PORTEX EMERGENCY CRICOTHYROIDOTOMY KITSmiths Medical2005-05-26
K013241ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.2002-02-21
K013252PATIL EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.2002-02-21
K013916MELKER EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.2001-12-20
K010016MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETERCook, Inc.2001-10-09
K962312KEY CHAIN EMERGENCY AIRWAYFfrench Pocket Emergency Airway, Inc.1997-06-17
K952401ABELSON CRICOTHYROTOMY CANNULAGilbert Surgical Instruments, Inc.1995-07-11
K85334531ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE31st. Centruy Medical Corp.1985-10-01
K790650WEISS EMERGENCY AIRWAY SYSTEMIntl. Medical Devices , Ltd.1979-06-27