# K062364: I-Scope 200

- Pathway: 510(k) (Traditional)
- Applicant: Dongjin Medical Co., Ltd.
- Decided: Dec 6, 2006 after 114 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K771653 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003723: 3M Littmann, 3M Company (2001) Summary page 1.
- K031446: Jabes Electronic Stethoscope, Gs Technology Co., Ltd. (2003) Summary page 1.

## Indications for use
The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.

Source page: https://510kreport.com/device/K062364
Methodology: https://510kreport.com/methodology