TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050— 510(k) K051583
Substantially EquivalentTiara Medical Systems, Inc.
FDA 510(k) clearance K051583 for TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050, Substantially Equivalent on 2005-11-04. Applicant: Tiara Medical Systems, Inc..
Clearance details
- Applicant
- Tiara Medical Systems, Inc.
- Product code
- Code BZD
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lakewood, OH, 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.