The following data is part of a premarket notification filed by Stevenson Industries, Inc. with the FDA for Cpap/pro Cpap Interface.
| Device ID | K992384 |
| 510k Number | K992384 |
| Device Name: | CPAP/PRO CPAP INTERFACE |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | STEVENSON INDUSTRIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf STEVENSON INDUSTRIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-16 |
| Decision Date | 1999-12-01 |
| Summary: | summary |