The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Aesculon Chf, Hypertension & Pacemaker Clinic.
| Device ID | K070985 |
| 510k Number | K070985 |
| Device Name: | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2008-02-01 |
| Summary: | summary |