The following data is part of a premarket notification filed by Intl. Biomedics, Inc. with the FDA for Infant Life Support Module-20.
| Device ID | K854065 |
| 510k Number | K854065 |
| Device Name: | INFANT LIFE SUPPORT MODULE-20 |
| Classification | Incubator, Neonatal Transport |
| Applicant | INTL. BIOMEDICS, INC. 2409 NORTH MAIN Cleburne, TX 76031 |
| Contact | Laddie L Davis |
| Correspondent | Laddie L Davis INTL. BIOMEDICS, INC. 2409 NORTH MAIN Cleburne, TX 76031 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-04 |
| Decision Date | 1986-01-16 |