FDA.reportPublic FDA data

510(k) K992553

Device
IQ CHAMBERS
Applicant
DORMER LABORATORIES, INC.
510(k) number
K992553
Product code
LDH  
Decision
Substantially Equivalent (SESE)
Decision date
2000-04-12
Date received
1999-07-30
Regulation
510(k) Premarket Notification
Classification name
System, Delivery, Allergen And Vaccine
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DANIEL MANELLI
Address
2000 M St., NW 7th Floor Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

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