Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1126271

FEI Number

1000263641

Entity Name

BioClinica, Inc.

City/State/Country

Philadelphia, PA, US

Establishment Address

1818 Market Street, Philadelphia, PA 19103, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Bioclinica, Inc. (Owner Number: 10023650)

Owner / Operator Contact Address

1501 Grundy Lane, Suite A, Bristol, PA 19007, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101403

PMA Number

N/A

All Registered Proprietary Names

GI M12R Tel-O-Graph Clarius L20 HD3 Endoflip nasal tip catheter MAC 1200 IEM HMS-CS H12+ Welch Allyn ELI150C Watch BP HOME A Welch Allyn ELI280 Welch Allyn ELI250C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2010-10-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-03-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-01
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2025-03-13
LOS	N/A	N/A	Class N/A	N/A	2009-12-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-10-23
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2009-12-15
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-06-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-02-09
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2021-02-09
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2014-12-16

Official Correspondent

Christopher Levinton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioclinica, 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1126271. Last updated year: 2026. Please use registration number 1126271 when referencing this establishment in official correspondence.