REMSTAR AUTO A-FLEX— 510(k) K091319
Substantially EquivalentRespironics Inc., Sleep & Home Respiratory Group
FDA 510(k) clearance K091319 for REMSTAR AUTO A-FLEX, Substantially Equivalent on 2009-08-03. Applicant: Respironics Inc., Sleep & Home Respiratory Group.
Clearance details
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- Product code
- Code BZD
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrysville, PA, US
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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.