The following data is part of a premarket notification filed by Creative Biomedics, Inc. with the FDA for The Portable Family - Medi-facts Dx1 Portable Lite And Dx1 Portable Plus.
| Device ID | K964939 |
| 510k Number | K964939 |
| Device Name: | THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS |
| Classification | Calculator, Pulmonary Function Data |
| 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 | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-10 |
| Decision Date | 1997-03-06 |