OHIO 3300 INFANT WARMER SYSTEM— 510(k) K840858
Substantially EquivalentOhio Medical Products
FDA 510(k) clearance K840858 for OHIO 3300 INFANT WARMER SYSTEM, Substantially Equivalent on 1984-03-23. Applicant: Ohio Medical Products. Device class: 2.
Clearance details
- Applicant
- Ohio Medical Products
- 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
- Walker, MI, US
Recent devices under product code FMT
view allMore clearances from Ohio Medical Products
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 K840858
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 K840858.
Data sourced from openFDA. This site is unofficial and independent of the FDA.