Cleared Traditional

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

K060321 · American Diagnostic Corp. · Chemistry
May 2006
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K060321 is an FDA 510(k) clearance for the ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on May 15, 2006, 95 days after receiving the submission on February 9, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number K060321 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2006
Decision Date May 15, 2006
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DQD — Stethoscope, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1875

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