Cleared Traditional

K971699 - ARGOSY DYNAMEQ

K971699 is an FDA 510(k) clearance for ARGOSY DYNAMEQ, manufactured by Argosy Electronics. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K971699 · Argosy Electronics · Ear, Nose, Throat device
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Jul 1997
Decision
56d
Days
Class 1
Risk

K971699 is an FDA 510(k) clearance for the ARGOSY DYNAMEQ. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Argosy Electronics (Eden Prairie, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Argosy Electronics devices

FDA 510(k) Submission Details - K971699

510(k) Number K971699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1997
Decision Date July 03, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 90d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K971699.
JAZZ PP AGC-O, JAZZ PP
K972542 · Trutone · Jul 1997
TWIST PPAGC-1, TWIST PP
K972543 · Trutone · Jul 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605 · Resound Corp. · Jul 1997
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
K971296 · National Hearing Aid Dist., Inc. · Jun 1997
AUDALLION III HEARING SYSTEM
K971031 · Gn Danavox, Inc. · Jun 1997
DANAVOX MODELS 163/162 BTE
K971032 · Gn Danavox, Inc. · Jun 1997