HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER— 510(k) K962220
Substantially EquivalentMarquest Medical Products, Inc.
FDA 510(k) clearance K962220 for HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER, Substantially Equivalent on 1997-01-14. Applicant: Marquest Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Marquest Medical Products, Inc.
- Product code
- Code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code BZE
view all- K252066 — inspired Heated Breathing Circuit (510-008) +3 more
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- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
More clearances from Marquest Medical Products, Inc.
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
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.