Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319182

FEI Number

1319182

Entity Name

GLOTTAL ENT., INC.

City/State/Country

SYRACUSE, NY, US

Establishment Address

1201 E. FAYETTE ST., SYRACUSE, NY 13210, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

GLOTTAL ENTERPRISES, INC. (Owner Number: 1319182)

Owner / Operator Contact Address

1201 E. FAYETTE ST., SUITE #15, Syracuse, NY 13210, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K901609

PMA Number

N/A

All Registered Proprietary Names

PG-60 PG-20 EG2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKE	Transducer, Miniature Pressure	Physical Medicine	Class 1	890.1615	2018-03-13
KLX	Electroglottograph	Ear, Nose, Throat	Class 2	874.1325	1992-07-17

Official Correspondent

MARTIN ROTHENBERG

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLOTTAL ENTERPRISES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319182. Last updated year: 2026. Please use registration number 1319182 when referencing this establishment in official correspondence.