The following data is part of a premarket notification filed by Volker Healthcare, Inc. with the FDA for Volker Nursing Bed Model 2080e & 2090e.
| Device ID | K946208 |
| 510k Number | K946208 |
| Device Name: | VOLKER NURSING BED MODEL 2080E & 2090E |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | VOLKER HEALTHCARE, INC. 55 NORTHERN BLVD, SUITE 410 Great Neck, NY 11021 |
| Contact | Milton N Beneke, Jr. |
| Correspondent | Milton N Beneke, Jr. 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 | 1994-12-21 |
| Decision Date | 1995-03-14 |