SPINAUT-E, SPINAUT-I— 510(k) K150789

Substantially Equivalent

Imedicom Co., Ltd.

FDA 510(k) clearance K150789 for SPINAUT-E, SPINAUT-I, Substantially Equivalent on 2016-03-01. Applicant: Imedicom Co., Ltd..

Clearance details

Applicant: Imedicom Co., Ltd.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2015-03-25
Decision date: 2016-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.