The following data is part of a premarket notification filed by Innovision A/s with the FDA for Lci Option For Innocor.
| Device ID | K102047 |
| 510k Number | K102047 |
| Device Name: | LCI OPTION FOR INNOCOR |
| Classification | Calculator, Pulmonary Function Data |
| 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 | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-21 |
| Decision Date | 2011-11-01 |
| Summary: | summary |