Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221108

FEI Number

1221108

Entity Name

IVY BIOMEDICAL SYSTEMS, INC.

City/State/Country

Branford, CT, US

Establishment Address

11 BUSINESS PARK DR., Branford, CT 06405, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IVY BIOMEDICAL SYSTEMS, INC. (Owner Number: 1221108)

Owner / Operator Contact Address

11 BUSINESS PARK DR., --, Branford, CT 06405, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240087

PMA Number

N/A

All Registered Proprietary Names

CTM-400 Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor CTM300 UPMM Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Accessory Kit, 7600/7600EP 7700 7600 7800 RT Carbon ECG Leads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXO	Synchronizer, Ecg / Respirator, Radiographic	Radiology	Class 1	892.1970	2016-11-09
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-04-18
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2009-08-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2009-08-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2021-05-19
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2024-09-16
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2012-03-05
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-01-15
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2025-01-15

Official Correspondent

Felicia Piel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IVY BIOMEDICAL SYSTEMS, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22

Similar Registrations

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3042989733	MARKEN HEALTHTECH LIMITED	NASHIK Maharashtra, IN
3006897996	HOSPITAL & HOMECARE IMP. & EXP. CO., LTD	NANJING Jiangsu, CN
8031557	ANZAI MEDICAL CO, LTD.	SHINAGAWA-KU Tokyo, JP
1816267	LAFAYETTE INSTRUMENT CO., INC.	La Fayette, IN, US
3002821232	MARK ENTERPRISES	Nashik Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221108. Last updated year: 2026. Please use registration number 1221108 when referencing this establishment in official correspondence.