INNOVAMED SPHERE INC

FDA Device Registration & Listing · Fall River, MA, US · Registration 3043355869

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043355869
FEI Number
3043355869
Entity Name
INNOVAMED SPHERE INC
City/State/Country
Fall River, MA, US
Establishment Address
2 Bank St, Fall River, MA 02720, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
INNOVAMED SPHERE INC (Owner Number: 10095268)
Owner / Operator Contact Address
2 Bank Strret, Fall River, MA 02720, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K070500
PMA Number
N/A

All Registered Proprietary Names

BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2026-02-16
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2026-02-16

Official Correspondent

George Hattub

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INNOVAMED SPHERE INC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043355869. Last updated year: 2026. Please use registration number 3043355869 when referencing this establishment in official correspondence.
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