510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963701Substantially Equivalent

Soma Safe Enclosure

Nova Technology Corp., Bristol CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963701 is the FDA 510(k) clearance record for SOMA SAFE ENCLOSURE, a class II device, cleared for Nova Technology Corp. on under FDA product code FNL (Bed, Ac-Powered Adjustable Hospital). FDA records list 3 510(k) clearances for Nova Technology Corp., from to . As of , FDA records show no recalls naming K963701.

Clearance record

Decision date
Received
(130 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
Nova Technology Corp. 545 Middle St., Bristol CT
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