AMBER-CHEST— 510(k) K862616

Substantially Equivalent

Old Delft Corp. of America

FDA 510(k) clearance K862616 for AMBER-CHEST, Substantially Equivalent on 1986-09-02. Applicant: Old Delft Corp. of America.

Clearance details

Applicant: Old Delft Corp. of America
Product code: Code KPR
Advisory panel: Radiology
Date received: 1986-07-09
Decision date: 1986-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.