LIONHEART 3 MULTI-PARAMETER SIMULATOR— 510(k) K944257
Substantially EquivalentBio-Tek Instruments, Inc.
FDA 510(k) clearance K944257 for LIONHEART 3 MULTI-PARAMETER SIMULATOR, Substantially Equivalent on 1994-09-21. Applicant: Bio-Tek Instruments, Inc..
Clearance details
- Applicant
- Bio-Tek Instruments, Inc.
- Product code
- Code DRT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winooski, VT, US
Adverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
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.