K253196
- 510(k) number
- K253196
- Device name
- Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
- Applicant
- Midmark Corporation OH · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2026-06-12
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253196.pdf
Official FDA record: K253196
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.