PERSONAL HEARING SYSTEM— 510(k) K944041

Name: FDA 510(k) clearance K944041
Creator: U.S. Food and Drug Administration
Published: 1994-12-27

Substantially Equivalent

Resound Corp.

FDA 510(k) clearance K944041 for PERSONAL HEARING SYSTEM, Substantially Equivalent on 1994-12-27. Applicant: Resound Corp.. Device class: 2.

Clearance details

Applicant: Resound Corp.
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1994-08-18
Decision date: 1994-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRS

view all

K050654 — AMSINO I.V. START KIT2005-05-02
K001879 — INFUSION IV SET2001-11-20
K963722 — IV START KIT1996-11-27
K951167 — EMS I.V. START KIT1995-05-16
K950184 — B. BRAUN IV START KITS1995-03-15

More clearances from Resound Corp.

view all

K984547 — DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS1999-03-19
K974081 — RESOUND STEALTH CIC1997-12-12
K974257 — RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)1997-12-12
K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION1997-07-03
K970215 — AUDALLION II HEARING SYSTEM1997-03-31

Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.