The following data is part of a premarket notification filed by Ferno with the FDA for Ferno-washington Incubator Transporter,# 29-it.
| Device ID | K931346 |
| 510k Number | K931346 |
| Device Name: | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT |
| Classification | Incubator, Neonatal Transport |
| Applicant | FERNO 70 WEIL WAY Wilmington, OH 45177 |
| Contact | Eric Besanko |
| Correspondent | Eric Besanko FERNO 70 WEIL WAY Wilmington, OH 45177 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-17 |
| Decision Date | 1993-08-25 |