Vitalmax 830 Series
510(k) K913263
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913263 | Date10 Oct 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Vitalmax 830 Series is a physiological patient monitor designed for arrhythmia detection and alarm functionality, classified under FDA category Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms). This device continuously monitors cardiac activity to identify and alert clinicians to abnormal heart rhythms, supporting timely clinical intervention in cardiovascular care settings.
Supplied as a reusable medical device, the Vitalmax 830 Series is intended for use in hospital, surgery center, clinic, and specialty care environments. It adheres to FDA regulation 870.1025 and holds a Traditional 510(k) clearance (K913263) under the product code MHX, with a decision of Substantially Equivalent. The device is not third-party reviewed and requires proper maintenance and calibration to ensure accurate arrhythmia detection and reliable alarm performance.