MEDI-JECT— 510(k) K832847

Name: FDA 510(k) clearance K832847
Creator: U.S. Food and Drug Administration
Published: 1984-02-28

Substantially Equivalent

Jack H. Ritterskamp

FDA 510(k) clearance K832847 for MEDI-JECT, Substantially Equivalent on 1984-02-28. Applicant: Jack H. Ritterskamp. Device class: 2.

Clearance details

Applicant: Jack H. Ritterskamp
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 1983-08-22
Decision date: 1984-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K160860 — MiniMed Quick-serter2016-09-22
K141384 — WHISPERJECT AUTOINJECTOR2014-09-12

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.