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Simulscope Auscultation and Simulscope Bedside Auscultation System

by Delphi Consulting Group 510(k)

Active United States

510(k) K961937

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961937 Date9 Dec 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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