INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION— 510(k) K093788
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K093788 for INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION, Substantially Equivalent on 2010-03-08. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
Recent devices under product code MHX
view allMore clearances from Draeger Medical Systems, Inc.
view allAdverse 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K093788
K-number listed on FDA's recall record- Z-1104-2021 — Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
- Z-0258-2020 — The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
- Z-0939-2013 — Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093788.
Data sourced from openFDA. This site is unofficial and independent of the FDA.