The following data is part of a premarket notification filed by Curative Medical Inc. with the FDA for K Series Cpap Systems.
| Device ID | K123897 |
| 510k Number | K123897 |
| Device Name: | K SERIES CPAP SYSTEMS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CURATIVE MEDICAL INC. 6518 TAMARIND SKY LN. Fulshear, TX 77441 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney CURATIVE MEDICAL INC. 6518 TAMARIND SKY LN. Fulshear, TX 77441 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-03-13 |
| Summary: | summary |