The following data is part of a De Novo classification by Device Classification Under Section 513(f)(2)(de Novo) // 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 Fo with the FDA for Device Classification Under Section 513(f)(2)(de Novo) // 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 Device Classification Under Section 513(f)(2)(de Novo) Var Mp = { Version: '1.0.22', Domains: {'es':'esp.fd.
| DeNovo ID | DK800667 | 
| Device Name: | Device Classification Under Section 513(f)(2)(De Novo) // 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 Device Classification Under Section 513(f)(2)(De Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd | 
| Classification | Device Classification Under Section 513(f)(2)(De Novo) // 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 Device Classification Under Section 513(f)(2)(De Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd | 
| Applicant | |
| Contact | Device Classification Under Section 513(f)(2)(De N | 
| Product Code | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Ski | 
| CFR Regulation Number | Device Classification Under Section 513(f)(2)(De N [🔎] | 
| Decision | Device Classification Under Section 513(f)(2)(De Novo) // 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 Fo | 
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin | 
| Review Advisory Board | Device Classification Under Section 513(f)(2)(De Novo) // 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 Fo | 
| Classification Advisory | Device Classification Under Section 513(f)(2)(De Novo) // 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 Fo | 
| Type | Device Classification Under Section 513(f)(2)(De Novo) // 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 Fo | 
| Reclassification Order: | 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 |