The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Extended Care Nursing Home Bed.
Device ID | K900151 |
510k Number | K900151 |
Device Name: | INVACARE EXTENDED CARE NURSING HOME BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
Contact | James R Thaler |
Correspondent | James R Thaler INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-11 |
Decision Date | 1990-06-18 |