SELENITE F BROTH— 510(k) K850716

Substantially Equivalent

Rapid City Regional Hospital, Inc.

FDA 510(k) clearance K850716 for SELENITE F BROTH, Substantially Equivalent on 1985-03-22. Applicant: Rapid City Regional Hospital, Inc..

Clearance details

Applicant: Rapid City Regional Hospital, Inc.
Product code: Code JSJ
Advisory panel: Microbiology
Date received: 1985-02-22
Decision date: 1985-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rapid City, SD, US

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Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.