The following data is part of a premarket notification filed by Simplex Medical Systems, Inc. with the FDA for Simplex Neonatal Breathing Circuit System.
| Device ID | K904396 |
| 510k Number | K904396 |
| Device Name: | SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM |
| Classification | Monitor, Breathing Frequency |
| Applicant | SIMPLEX MEDICAL SYSTEMS, INC. 3305 SPRINGMOUNTAIN ROAD, #60 Las Vegas, NV 89102 |
| Contact | James Weigl |
| Correspondent | James Weigl SIMPLEX MEDICAL SYSTEMS, INC. 3305 SPRINGMOUNTAIN ROAD, #60 Las Vegas, NV 89102 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1991-03-05 |