510(k) DEN200022
- Device
- Analytic for Hemodynamic Instability (AHI)
- Applicant
- Fifth Eye, Inc.
- 510(k) number
- DEN200022
- Product code
- QNV
- Decision
- Unknown (DENG)
- Decision date
- 2021-03-01
- Date received
- 2020-04-03
- Regulation
- 870.2220
- Classification name
- Adjunctive Hemodynamic Indicator With Decision Point
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jennifer A Baird
- Address
- 110 Miller Ave., Suite 300 Ann Arbor MI US 48104 48104
FDA Registration Numbers#
- 3006104191
Source Documents#
510(k) summary PDF not indicated by FDA