HLA-2000— 510(k) K790513

Name: FDA 510(k) clearance K790513
Creator: U.S. Food and Drug Administration
Published: 1979-05-31

Substantially Equivalent

Bdt Ent.

FDA 510(k) clearance K790513 for HLA-2000, Substantially Equivalent on 1979-05-31. Applicant: Bdt Ent.. Device class: 2.

Clearance details

Applicant: Bdt Ent.
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
Advisory panel: Cardiovascular
Date received: 1979-03-15
Decision date: 1979-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRM

view all

K221700 — AutoPulse NXT Resuscitation System2023-03-09
K211289 — RMU-2000 Automated Chest Compression System2021-11-09
K173553 — LUCAS 3 Chest Compression System2018-02-08
K161768 — LUCAS 3 Chest Compression System2016-11-09
K153628 — ROSC-U Mini Chest Compressor (RMCC)2016-01-30

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.