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Stethophone

FDA UDI

Class II (US FDA UDI)

by Sparrow Acoustics, Inc.

Identity

Trade Name
Stethophone FDA UDI
Generic Name
Electronic acoustic stethoscope FDA UDI
Device Name
Smartphone stethoscope software application for iPhones FDA UDI
Model / Reference
2.x.x FDA UDI
Description
Smartphone stethoscope software application for iPhones FDA UDI

Identifiers

Primary DI / UDI-DI
00860011561705 FDA UDI
510(k) Number
K231551 FDA UDI
FDA Product Code
DQD FDA UDI
GMDN Term
Electronic acoustic stethoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1875 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electronic acoustic stethoscope

Stethophone by Sparrow Acoustics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electronic acoustic stethoscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sparrow Acoustics, Inc.

Sources (1)

  • FDA UDI d66d7a9a-5113-4e52-9b23-dc520f28af1f 34 fields · synced May 30, 2026