HEATER WIRE BREATHING CIRCUIT— 510(k) K873179
Substantially EquivalentLife Design Systems, Inc.
FDA 510(k) clearance K873179 for HEATER WIRE BREATHING CIRCUIT, Substantially Equivalent on 1988-03-31. Applicant: Life Design Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Life Design Systems, 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
- Franklin, WI, US
Recent devices under product code BZE
view all- K252066 — inspired Heated Breathing Circuit (510-008) +3 more
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- K243244 — Heated Breathing Tube
- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
More clearances from Life Design Systems, 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.