Stethophone Pro

Basic Information

• Brand Name: Stethophone Pro
• Primary DI: 00860011561729
• Version / Model: 3.x.x
• Company Name: Sparrow Acoustics Inc.
• Labeler DUNS: 201872068
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-13
• Public Version: 2
• Public Version Date: 2026-02-19
• Public Version Status: Update
• Public Device Record Key: 6d729f2f-30ed-4343-a9cb-4ef8301e1b32
• Distribution End Date: 2026-02-18

Device Description

Smartphone stethoscope software application with AI for iPhones - Rx only (versions 3.0.x to 3.7.x)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQD	Stethoscope, Electronic	Cardiovascular	870.1875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13754	Electronic acoustic stethoscope	An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011561729	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240901	000