DeNovo ID | DEN200022 |
Device Name: | Analytic For Hemodynamic Instability (AHI) |
Classification | Adjunctive Hemodynamic Indicator With Decision Point |
Applicant | Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor, MI 48104 |
Contact | Jennifer A Baird |
Product Code | QNV |
CFR Regulation Number | 870.2220 [🔎] |
Decision | Granted (DENG) |
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 | Cardiovascular |
Classification Advisory | Cardiovascular |
Type | Direct |
Date Received | 2020-04-03 |
Decision Date | 2021-03-01 |
Reclassification Order: | Reclassification Order |