Real-Time

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: REAL-TIME FDA UDI
Generic Name: Electroglottograph FDA UDI
Device Name: Real-Time Spectrogram Software FDA UDI
Model / Reference: 5129 FDA UDI
Description: Real-Time Spectrogram Software FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333229789 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

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

Similar devices

Also classified as Electroglottograph.

Two Channel Electroglottograph EG2-PCX2 — Glottal Enterprises, Inc. · Class II
PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
ADSV — PENTAX of America, Inc. · Class II
SONA-SPEECH II — PENTAX of America, Inc. · Class II
NASOMETER II — PENTAX of America, Inc. · Class II
REAL-TIME — PENTAX of America, Inc. · Class II
PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
NASOMETER II — 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 e9cfbe03-7e0d-4cb5-a03f-1bf568a14019 33 fields · synced Jun 1, 2026