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510(k) K190854

Device
Therm-X
Applicant
Zenith Technical Innovations
510(k) number
K190854
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 &
Decision
Substantially Equivalent (SESE)
Decision date
2019-05-10
Date received
2019-04-02
Regulation
510(k) Premarket Notification
Classification name
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
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
Physical Medicine
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Greg Binversie
Address
1396 St. Paul Ave. Gurnee IL US 60031 60031

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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