The following data is part of a premarket notification filed by Ela Medical Inc with the FDA for Synescope, Easyscope, Synecom, Holterreader.
| Device ID | K042002 |
| 510k Number | K042002 |
| Device Name: | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ELA MEDICAL INC 2950 XENIUM LN. N. STE. 120 Plymouth, MN 55441 |
| Contact | Susan Olive |
| Correspondent | Susan Olive ELA MEDICAL INC 2950 XENIUM LN. N. STE. 120 Plymouth, MN 55441 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08031527015040 | K042002 | 000 |
| 08031527015033 | K042002 | 000 |
| 08031527014944 | K042002 | 000 |
| 08031527014913 | K042002 | 000 |
| 08031527014296 | K042002 | 000 |
| 08031527014289 | K042002 | 000 |
| 08031527013435 | K042002 | 000 |