The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Aesculon C2, Aesculon Chf Clinic C2, Aesculon Hypertension Clinic C2 And Aesculon Pacemaker Clinic C2.
| Device ID | K081035 |
| 510k Number | K081035 |
| Device Name: | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 |
| 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 | 2008-04-11 |
| Decision Date | 2008-05-30 |
| Summary: | summary |