510(k) K233249
- Device
- APPRAISE-HRI
- Applicant
- The Surgeon General, Department of the Army (TSG-DA)
- 510(k) number
- K233249
- Product code
- SAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-05
- Date received
- 2023-09-28
- Regulation
- 870.2220
- Classification name
- Adjunctive Hemodynamic Indicator With Decision Point For Military Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Emily Badraslionglu
- Address
- U.S. Army Medical Materiel Research & Development Command; Attn: Fcmr-Ora, 1430 Veterans Dr. Fort Dietrick MD US 21702 21702