DATUM— 510(k) K942799

Name: FDA 510(k) clearance K942799
Creator: U.S. Food and Drug Administration
Published: 1995-04-13

Substantially Equivalent

Blease USA, Inc.

FDA 510(k) clearance K942799 for DATUM, Substantially Equivalent on 1995-04-13. Applicant: Blease USA, Inc.. Device class: 2.

Clearance details

Applicant: Blease USA, Inc.
Product code: Code CAD
Device class: Class 2
Regulation: 21 CFR 868.5880
Advisory panel: Anesthesiology
Date received: 1994-06-15
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynnwood, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAD

view all

K240375 — V80 Anesthetic Vaporizer (V80)2024-10-31
K172702 — Tec 820, Tec 8502018-01-04
K150167 — V60 Anesthetic Vaporizer2015-06-30
K110608 — SEVOFLURANE VAPORIZER ADAPTOR2011-07-20
K060331 — SIGMA ALPHA VAPORIZER2006-05-10

More clearances from Blease USA, Inc.

view all

K051629 — BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 20002005-09-23

Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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.