ISOLETTE INFANT INCUBATOR, MODEL C2000E— 510(k) K031387
Substantially EquivalentHill-Rom Manufacturing, Inc.
FDA 510(k) clearance K031387 for ISOLETTE INFANT INCUBATOR, MODEL C2000E, Substantially Equivalent on 2003-08-01. Applicant: Hill-Rom Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Hill-Rom Manufacturing, Inc.
- Product code
- Code FMZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hatboro, PA, US
Recent devices under product code FMZ
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- K032772 — MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
- K014094 — MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
Adverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.