MC ACCLAIM Q6000 BED— 510(k) K951161

Name: FDA 510(k) clearance K951161
Creator: U.S. Food and Drug Administration
Published: 1995-05-09

Substantially Equivalent

Janco Consulting Services

FDA 510(k) clearance K951161 for MC ACCLAIM Q6000 BED, Substantially Equivalent on 1995-05-09. Applicant: Janco Consulting Services. Device class: 2.

Clearance details

Applicant: Janco Consulting Services
Product code: Code FNL
Device class: Class 2
Regulation: 21 CFR 880.5100
Advisory panel: General Hospital
Date received: 1995-03-14
Decision date: 1995-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: L5n 1n7, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.