IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2— 510(k) K131901
Substantially Equivalent3B Medical, Inc.
FDA 510(k) clearance K131901 for IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2, Substantially Equivalent on 2013-12-23. Applicant: 3B Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- 3B Medical, Inc.
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Wales, FL, US
Recent devices under product code BZD
view allMore clearances from 3B Medical, Inc.
view allAdverse 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.