BIOMA 5000— 510(k) K880036

Substantially Equivalent

E.B.S., Inc.

FDA 510(k) clearance K880036 for BIOMA 5000, Substantially Equivalent on 1988-03-07. Applicant: E.B.S., Inc..

Clearance details

Applicant: E.B.S., Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1988-01-05
Decision date: 1988-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.