The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Portable Ecscope 12i.
| Device ID | K080036 |
| 510k Number | K080036 |
| Device Name: | PORTABLE ECSCOPE 12I |
| Classification | Electrocardiograph |
| Applicant | DYANSYS, INC. 577 AIRPORT BLVD. SUITE 610 Burlingame, CA 95032 |
| Contact | Srini Nageshwar |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-01-07 |
| Decision Date | 2008-01-16 |
| Summary: | summary |