The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for The Portable Ansiscope.
| Device ID | K071168 |
| 510k Number | K071168 |
| Device Name: | THE PORTABLE ANSISCOPE |
| Classification | Electrocardiograph |
| Applicant | DYANSYS, INC. 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel DYANSYS, INC. 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-27 |
| Decision Date | 2007-08-31 |
| Summary: | summary |