The following data is part of a premarket notification filed by Creative Biomedics, Inc. with the FDA for Dx1.
| Device ID | K951227 |
| 510k Number | K951227 |
| Device Name: | DX1 |
| Classification | Spirometer, Diagnostic |
| Applicant | CREATIVE BIOMEDICS, INC. 934-B CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | Daniel Brown |
| Correspondent | Daniel Brown CREATIVE BIOMEDICS, INC. 934-B CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1995-08-11 |