The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Flowtron Air, Ac400/2 Air.
Device ID | K850910 |
510k Number | K850910 |
Device Name: | HUNTLEIGH FLOWTRON AIR, AC400/2 AIR |
Classification | 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 Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 103-1A CHURCH ST. Aberdeen, NJ 07747 |
Contact | James Britton |
Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 103-1A CHURCH ST. Aberdeen, NJ 07747 |
Product Code | 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 Radiation-Emitting Products Vaccines, Blood & |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-05 |
Decision Date | 1985-08-20 |