SAFTI-BRACELET— 510(k) K853418

Name: FDA 510(k) clearance K853418
Creator: U.S. Food and Drug Administration
Published: 1985-09-20

Substantially Equivalent

Advanced Biosearch Assn.

FDA 510(k) clearance K853418 for SAFTI-BRACELET, Substantially Equivalent on 1985-09-20. Applicant: Advanced Biosearch Assn.. Device class: 1.

Clearance details

Applicant: Advanced Biosearch Assn.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1985-08-14
Decision date: 1985-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.