FIRST RESPONSE EMERG. MEDICAL SYS BONES— 510(k) K841899

Name: FDA 510(k) clearance K841899
Creator: U.S. Food and Drug Administration
Published: 1984-07-23

Substantially Equivalent

Reed Products, Inc.

FDA 510(k) clearance K841899 for FIRST RESPONSE EMERG. MEDICAL SYS BONES, Substantially Equivalent on 1984-07-23. Applicant: Reed Products, Inc.. Device class: 1.

Clearance details

Applicant: Reed Products, Inc.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1984-05-07
Decision date: 1984-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Reed Products, Inc.

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K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS1984-08-14
K841897 — FIRST RESPONSE EMERG. MEDICAL SYSTEM1984-07-23
K841900 — FIRST RESPONSE EMERG. EYE INJURIES1984-07-23

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.