ALLEN MALLEABLE ANESTHESIA SCREEN— 510(k) K873370

Name: FDA 510(k) clearance K873370
Creator: U.S. Food and Drug Administration
Published: 1987-09-11

Substantially Equivalent

Edgewater Medical Equipment Systems

FDA 510(k) clearance K873370 for ALLEN MALLEABLE ANESTHESIA SCREEN, Substantially Equivalent on 1987-09-11. Applicant: Edgewater Medical Equipment Systems. Device class: 1.

Clearance details

Applicant: Edgewater Medical Equipment Systems
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1987-08-21
Decision date: 1987-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mayfield Hts., OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.