The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx4042/mc4044 Series Simulcath(tm).
| Device ID | K922323 |
| 510k Number | K922323 |
| Device Name: | MX4042/MC4044 SERIES SIMULCATH(TM) |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1994-06-14 |