DMI BLOOD GAS ANALYZER/CARTRIDGE— 510(k) K924758

Name: FDA 510(k) clearance K924758
Creator: U.S. Food and Drug Administration
Published: 1992-12-03

Substantially Equivalent

Diamond Medical, Inc.

FDA 510(k) clearance K924758 for DMI BLOOD GAS ANALYZER/CARTRIDGE, Substantially Equivalent on 1992-12-03. Applicant: Diamond Medical, Inc.. Device class: 2.

Clearance details

Applicant: Diamond Medical, Inc.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1992-09-23
Decision date: 1992-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHL

view all

K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

More clearances from Diamond Medical, Inc.

view all

K915087 — DMI BLOD GAS ANALYZER/CARTRIDGE1992-01-08
K874709 — DIAMOND MEDICAL, INC. MODEL DM 8001988-02-08
K874710 — DIAMOND MEDICAL, INC. MODEL DM 6001988-02-08
K875369 — MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT1988-02-05
K863298 — DIAMOND MEDICAL, INC., MODEL DM 7001987-03-17

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.