# K993623: Gemini E

- Pathway: 510(k) (Traditional)
- Applicant: Allen Medical Instruments Corp.
- Decided: Jun 23, 2000 after 241 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Simuliscope Bedside Auscultation System: named in the summary without a submission number

## Indications for use
Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional. Normal auscultation as above by a health care professional who wears hearing aids. To allow four other listeners (e.g. students) to listen together with a health care professional.

Source page: https://510kreport.com/device/K993623
Methodology: https://510kreport.com/methodology