INFANT RADIANT WARMER - MODELS IW910 AND IW920— 510(k) K970432
Substantially EquivalentFisher & Paykel Electronics , Ltd.
FDA 510(k) clearance K970432 for INFANT RADIANT WARMER - MODELS IW910 AND IW920, Substantially Equivalent on 1997-05-07. Applicant: Fisher & Paykel Electronics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Electronics , Ltd.
- 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
- Auckland, NZ
Recent devices under product code FMT
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view all- K973161 — CPAP HUMIDIFIER (HC 200)
- K972885 — SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
- K971695 — SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
- K971461 — SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
- K953392 — HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
Adverse 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 K970432
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 K970432.
Data sourced from openFDA. This site is unofficial and independent of the FDA.