FDA.reportPublic FDA data

510(k) K780558

Device
BOTTLE BREATHING DEVICE
Applicant
B & F MEDICAL PRODUCTS, INC.
510(k) number
K780558
Product code
BYO  
Decision
Substantially Equivalent (SESE)
Decision date
1978-05-26
Date received
1978-04-05
Regulation
868.5220
Classification name
Bottle, Blow
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

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 BYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924541EPIDURAL MINIPACKConcord/Portex1993-07-09
K913527HYPERFREEKist Intl.1992-01-21
K7804072C7125 BLOW BOTTLETravenol Laboratories, S.A.1978-04-10

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