The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Icon, Model C3.
| Device ID | K082242 |
| 510k Number | K082242 |
| Device Name: | ICON, MODEL C3 |
| Classification | Plethysmograph, Impedance |
| Applicant | OSYPKA MEDICAL, INC. 7855 IVANHOE AVE., SUITE 226 La Jolla, CA 92037 |
| Contact | Markus Osypka |
| Correspondent | Markus Osypka OSYPKA MEDICAL, INC. 7855 IVANHOE AVE., SUITE 226 La Jolla, CA 92037 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-10-08 |
| Summary: | summary |