MVM 4000 HOLTER IV RECORDER— 510(k) K853985

Substantially Equivalent

Mountain View Medical

FDA 510(k) clearance K853985 for MVM 4000 HOLTER IV RECORDER, Substantially Equivalent on 1985-11-06. Applicant: Mountain View Medical.

Clearance details

Applicant: Mountain View Medical
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1985-09-27
Decision date: 1985-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Corona, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.