Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014174631

FEI Number

3028631080

Entity Name

PRONIA MEDICAL SYSTEMS

City/State/Country

Lewisburg, PA, US

Establishment Address

803 Springhouse Dr, Lewisburg, PA 17837, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pronia Medical Systems (Owner Number: 10028182)

Owner / Operator Contact Address

22 West Road, South Salem, NY 10590, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081388

PMA Number

N/A

All Registered Proprietary Names

GlucoCare Intensive Glycemic Control System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2009-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pronia Medical Systems

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 3014174631. Last updated year: 2026. Please use registration number 3014174631 when referencing this establishment in official correspondence.