The following data is part of a premarket notification filed by Simplex Medical Systems, Inc. with the FDA for Neonatal Breathing Circuit Modification.
| Device ID | K932288 |
| 510k Number | K932288 |
| Device Name: | NEONATAL BREATHING CIRCUIT MODIFICATION |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| 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 | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1994-12-30 |