The following data is part of a premarket notification filed by Equi-tron Mfg., Inc. with the FDA for Series 2000 Adjustable Bed.
Device ID | K903904 |
510k Number | K903904 |
Device Name: | SERIES 2000 ADJUSTABLE BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | EQUI-TRON MFG., INC. 4600 WITMER INDUSTRIAL ESTATES Niagara Falls, NY 14305 |
Contact | John Porter |
Correspondent | John Porter EQUI-TRON MFG., INC. 4600 WITMER INDUSTRIAL ESTATES Niagara Falls, NY 14305 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-23 |
Decision Date | 1990-10-12 |