510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903904Substantially Equivalent

Series 2000 Adjustable Bed

Equi-Tron Mfg., Inc., Niagara Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903904 is the FDA 510(k) clearance record for SERIES 2000 ADJUSTABLE BED, a class II device, cleared for Equi-Tron Mfg., Inc. on under FDA product code FNL (Bed, Ac-Powered Adjustable Hospital). FDA records list 5 510(k) clearances for Equi-Tron Mfg., Inc., from to . As of , FDA records show no recalls naming K903904.

Clearance record

Decision date
Received
(50 days to decision)
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Applicant
Equi-Tron Mfg., Inc. 4600 Witmer Industrial Estates, Niagara Falls NY
Third party review
No

Clearances, product code FNL

Trailing 12 months

FDA records hold no clearances under product code FNL in the trailing twelve months.

FDA records show no clearances under product code FNL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260