510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972115Substantially Equivalent

Volker Hospital Bed, Model K960

Volker Healthcare, Inc., Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972115 is the FDA 510(k) clearance record for VOLKER HOSPITAL BED, MODEL K960, a class II device, cleared for Volker Healthcare, Inc. on under FDA product code FNL (Bed, Ac-Powered Adjustable Hospital). FDA records list 2 510(k) clearances for Volker Healthcare, Inc., from to . As of , FDA records show no recalls naming K972115.

Clearance record

Decision date
Received
(85 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
Volker Healthcare, Inc. 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Statement
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