INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL— 510(k) K033957

Name: FDA 510(k) clearance K033957
Creator: U.S. Food and Drug Administration
Published: 2004-05-14

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K033957 for INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL, Substantially Equivalent on 2004-05-14. Applicant: Draeger Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Draeger Medical Systems, Inc.
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2003-12-22
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MHX

view all

K260656 — Carescape ONE +6 more2026-09-01
K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display2026-08-28
K260579 — Infinity® Acute Care System (IACS) VG8.12026-08-20
K251508 — Telemetry Monitor (iT30, iT50)2026-08-06
K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

More clearances from Draeger Medical Systems, Inc.

view all

K243606 — Babyroo TN3002025-01-17
K240312 — Infinity CentralStation Wide2024-08-01
K233834 — Infinity Gateway Suite2024-07-12
K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+2023-10-17
K230278 — Babyroo TN3002023-05-30

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.