510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970340Substantially Equivalent

Air Conduction Assistive Listening Device.personal Amplifier

Bellab, Gothenburg, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970340 is the FDA 510(k) clearance record for AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER, a class II device, cleared for Bellab on under FDA product code LZI (Device, Assistive Listening). FDA records list one 510(k) clearance for Bellab. As of , FDA records show no recalls naming K970340.

Clearance record

Decision date
Received
(56 days to decision)
Product code
LZI Device, Assistive Listening
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bellab Gustaf Werners Gata 2, Gothenburg, SE
510(k) summary
Summary
Third party review
No

Clearances, product code LZI

Trailing 12 months

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

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