The following data is part of a premarket notification filed by Curative Medical Inc. with the FDA for K Series Cpap System With Heated Humidifer.
| Device ID | K120285 |
| 510k Number | K120285 |
| Device Name: | K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CURATIVE MEDICAL INC. 63 CHICORY CT Lake Jackson, TX 77566 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney CURATIVE MEDICAL INC. 63 CHICORY CT Lake Jackson, TX 77566 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-31 |
| Decision Date | 2012-07-02 |
| Summary: | summary |