ENTERALITE— 510(k) K954735
Substantially Equivalent - Subject to Tracking Reg.Zevex Intl., Inc.
FDA 510(k) clearance K954735 for ENTERALITE, Substantially Equivalent - Subject to Tracking Reg. on 1996-04-15. Applicant: Zevex Intl., Inc..
Clearance details
- Applicant
- Zevex Intl., Inc.
- Product code
- Code LZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- West Jordan, UT, US
Adverse events under product code LZH
product code LZH- Death
- 12
- Malfunction
- 4,186
- Total
- 4,198
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.