AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006— 510(k) K991484
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K991484 for AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006, Substantially Equivalent on 1999-05-13. Applicant: Allegiance Healthcare Corp.. Device class: 2.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mcgraw Park, IL, US
Recent devices under product code BTT
view allMore clearances from Allegiance Healthcare Corp.
view all- K023673 — AIRLIFE DEMAND NASAL CANNULA
- K023419 — TRILAMINATE DRAPES/TIBURON
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.