Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)— 510(k) K253196
Substantially EquivalentMidmark Corporation
FDA 510(k) clearance K253196 for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400), Substantially Equivalent on 2026-06-12. Applicant: Midmark Corporation. Device class: 2.
Clearance details
- Applicant
- Midmark Corporation
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Versailles, OH, US
Recent devices under product code MWI
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view all- K251626 — Midmark Dental Delivery System
- K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
- K201667 — Midmark Extraoral Imaging System (EOIS)
- K163337 — Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
- K161909 — IQvitals Zone
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.