510(k) K102047 ยท BZC Calculator, Pulmonary Function Data
LCI OPTION FOR INNOCOR
| Applicant | Innovision A/S, Lake Bluff IL, US |
| Decision | Substantially Equivalent, Nov 1, 2011 |
| Received | Jul 21, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2016 | Innovision A/S Innocor Cardiopulmonary Exercise and Lung Function Testing System
Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters. Terminated |
BZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.