The following data is part of a premarket notification filed by Synectics Medical, Inc. with the FDA for Synergy Ii.
| Device ID | K942445 |
| 510k Number | K942445 |
| Device Name: | SYNERGY II |
| Classification | Table, Cystometric, Electric |
| Applicant | SYNECTICS MEDICAL, INC. 1425 GREENWAY DR., #600 Irving, TX 75038 |
| Contact | David Woodruff |
| Correspondent | David Woodruff SYNECTICS MEDICAL, INC. 1425 GREENWAY DR., #600 Irving, TX 75038 |
| Product Code | MMZ |
| CFR Regulation Number | 876.4890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-23 |
| Decision Date | 1994-11-22 |