DIGITAL PULSE METER HRM-100E & ETC.— 510(k) K850449

Name: FDA 510(k) clearance K850449
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

Sanyo Electric, Inc.

FDA 510(k) clearance K850449 for DIGITAL PULSE METER HRM-100E & ETC., Substantially Equivalent on 1986-12-04. Applicant: Sanyo Electric, Inc.. Device class: 2.

Clearance details

Applicant: Sanyo Electric, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1985-02-05
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hyogo, Japan, JP

Download summary PDF View on FDA.gov ↗

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K822692 — DIGITAL PULSE METER (73 BWS) #HRM-100E1982-10-15
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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.