BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20— 510(k) K110383

Substantially Equivalent

A Plus Medical

FDA 510(k) clearance K110383 for BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20, Substantially Equivalent on 2011-08-01. Applicant: A Plus Medical.

Clearance details

Applicant: A Plus Medical
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2011-02-10
Decision date: 2011-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.