FDA.reportPublic FDA data

510(k) K001714

Device
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
Applicant
MERCURY MEDICAL
510(k) number
K001714
Product code
NHK  
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-03
Date received
2000-06-05
Regulation
868.5905
Classification name
Resuscitator, Manual, Non Self-inflating
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RON RUPENSKI
Address
11300 49th St. N. Clearwater FL US 33762 33762

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERA Plus Medical2009-11-23
K020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.2002-02-11
K013308VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.2001-12-20
K970785SIMS HYPERINFLATION BAG SYSTEMSims1997-06-13
K952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.1995-06-08
K942571HYPER-INFLATION BAGMed-Plastics Intl., Inc.1994-06-10
K940255HYPERINFLATION BAG SYSTEMNutec, Inc.1994-02-17
K894612INTERTECH NEWBORN HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.1989-09-08
K813317DISP. HYPERINFLATION BAG SYSTEMIntec Medical, Inc.1982-03-12

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