510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K944929Substantially Equivalent

Optima Delivery Bed (Models 33901, 33903, 33902, 33905)

Merivaara Instrumentarium Corp., Lahti, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944929 is the FDA 510(k) clearance record for OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905), a class I device, cleared for Merivaara Instrumentarium Corp. on under FDA product code FNK (Bed, Hydraulic, Adjustable Hospital). FDA records list 4 510(k) clearances for Merivaara Instrumentarium Corp., from to . As of , FDA records show no recalls naming K944929.

Clearance record

Decision date
Received
(47 days to decision)
Product code
FNK Bed, Hydraulic, Adjustable Hospital
Regulation
21 CFR 880.5110
Device class
Class I
Review panel
General Hospital
Applicant
Merivaara Instrumentarium Corp. Fin-15150, Lahti, FI
510(k) summary
Summary
Third party review
No

Clearances, product code FNK

Trailing 12 months

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

FDA records show no clearances under product code FNK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNK, 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