The following data is part of a premarket notification filed by Volker Healthcare, Inc. with the FDA for Volker Hospital Bed, Model K960.
Device ID | K972115 |
510k Number | K972115 |
Device Name: | VOLKER HOSPITAL BED, MODEL K960 |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | VOLKER HEALTHCARE, INC. 55 NORTHERN BLVD, SUITE 410 Great Neck, NY 11021 |
Contact | Milton N Beneke |
Correspondent | Milton N Beneke VOLKER HEALTHCARE, INC. 55 NORTHERN BLVD, SUITE 410 Great Neck, NY 11021 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-05 |
Decision Date | 1997-08-29 |