The following data is part of a premarket notification filed by Ferno-washington, Inc. with the FDA for Ferno Washington Incubator Transporter, Mod. 35-it.
Device ID | K932417 |
510k Number | K932417 |
Device Name: | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT |
Classification | Incubator, Neonatal Transport |
Applicant | FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington, OH 45177 |
Contact | Renee Walz |
Correspondent | Renee Walz FERNO-WASHINGTON, INC. 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 | 1993-05-18 |
Decision Date | 1993-09-09 |