OHMEDA 5000 INFANT WARMER SYSTEM— 510(k) K851449
Substantially EquivalentOhmeda Medical
FDA 510(k) clearance K851449 for OHMEDA 5000 INFANT WARMER SYSTEM, Substantially Equivalent on 1985-06-07. Applicant: Ohmeda Medical. Device class: 2.
Clearance details
- Applicant
- Ohmeda Medical
- Product code
- Code FMT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5130
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code FMT
view allMore clearances from Ohmeda Medical
view allAdverse events under product code FMT
product code FMT- Death
- 4
- Malfunction
- 3,074
- Total
- 3,078
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 K851449
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K851449.
Data sourced from openFDA. This site is unofficial and independent of the FDA.