The following data is part of a premarket notification filed by Innovision A/s with the FDA for Innocor Ergospirometry System (inn00010), The Basic Innocor Including Breath-by-breath System (inn00400), Nibp(inn00500).
| Device ID | K083879 |
| 510k Number | K083879 |
| Device Name: | INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) |
| Classification | Spirometer, Diagnostic |
| Applicant | INNOVISION A/S 10 E. SCRANTON AVE. SUITE 201 Lake Bluff, IL 60044 |
| Contact | H. Carl Jenkins |
| Correspondent | H. Carl Jenkins INNOVISION A/S 10 E. SCRANTON AVE. SUITE 201 Lake Bluff, IL 60044 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-02-23 |
| Summary: | summary |