NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI— 510(k) K011125
Substantially EquivalentHudson Respiratory Care, Inc.
FDA 510(k) clearance K011125 for NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI, Substantially Equivalent on 2001-06-13. Applicant: Hudson Respiratory Care, Inc..
Clearance details
- Applicant
- Hudson Respiratory Care, Inc.
- Product code
- Code CAT
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
Adverse events under product code CAT
product code CAT- Death
- 5
- Malfunction
- 544
- Other
- 2
- Total
- 551
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.