CLEARSTAR ENTERAL NUTRITION PUMP— 510(k) K981541
Substantially EquivalentFrantz Medical Development, Ltd.
FDA 510(k) clearance K981541 for CLEARSTAR ENTERAL NUTRITION PUMP, Substantially Equivalent on 1998-08-13. Applicant: Frantz Medical Development, Ltd..
Clearance details
- Applicant
- Frantz Medical Development, Ltd.
- Product code
- Code LZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, 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.