PROLONG, MODELS PL50, PL100, PL150— 510(k) K001129
Substantially EquivalentLife-Tech Intl., Inc.
FDA 510(k) clearance K001129 for PROLONG, MODELS PL50, PL100, PL150, Substantially Equivalent on 2000-07-06. Applicant: Life-Tech Intl., Inc..
Clearance details
- Applicant
- Life-Tech Intl., Inc.
- Product code
- Code CAZ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stafford, TX, US
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
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.