Sona-Speech Ii

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: SONA-SPEECH II FDA UDI
Generic Name: Electroglottograph FDA UDI
Device Name: Sona-Speech II FDA UDI
Model / Reference: 3650 FDA UDI
Description: Sona-Speech II FDA UDI

Identifiers

Catalog Number: N/A FDA UDI
Primary DI / UDI-DI: 04961333229635 FDA UDI
FDA Product Code: KLX FDA UDI
GMDN Term: Electroglottograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1325 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electroglottograph

Sona-Speech Ii by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electroglottograph.

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PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
NASOMETER II — PENTAX of America, Inc. · Class II
N/Al — PENTAX of America, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: PENTAX of America, Inc.

Sources (1)

FDA UDI da2d9081-47b2-4cb2-af84-91f70531939e 34 fields · synced Jun 8, 2026