The following data is part of a premarket notification filed by Vail Products, Inc. with the FDA for Vail 3000 Bed Enclosure.
Device ID | K963589 |
510k Number | K963589 |
Device Name: | VAIL 3000 BED ENCLOSURE |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | VAIL PRODUCTS, INC. 235 FIRST ST. Toledo, OH 43605 |
Contact | Nancy Vail |
Correspondent | Nancy Vail VAIL PRODUCTS, INC. 235 FIRST ST. Toledo, OH 43605 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-09 |
Decision Date | 1997-04-21 |