The following data is part of a premarket notification filed by Compumedics Usa, Ltd. with the FDA for Compumedics Summit Ip.
| Device ID | K040194 |
| 510k Number | K040194 |
| Device Name: | COMPUMEDICS SUMMIT IP |
| Classification | Ventilatory Effort Recorder |
| Applicant | COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE El Paso, TX 79912 |
| Contact | Elvira Garcia |
| Correspondent | Elvira Garcia COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE El Paso, TX 79912 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-28 |
| Decision Date | 2004-04-23 |
| Summary: | summary |