THE HEART PROTECTOR— 510(k) K944481

Name: FDA 510(k) clearance K944481
Creator: U.S. Food and Drug Administration
Published: 1995-04-10

Substantially Equivalent

Garan Scientific, Inc.

FDA 510(k) clearance K944481 for THE HEART PROTECTOR, Substantially Equivalent on 1995-04-10. Applicant: Garan Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Garan Scientific, Inc.
Product code: Code NXB
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1994-09-13
Decision date: 1995-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NXB

view all

K882731 — TAB PAK1988-12-14
K833311 — NITROGLYCERINE CONTAINER1984-02-04

Adverse events under product code NXB

product code NXB

Death: 3
Other: 1
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.