Otsuka America Pharmaceutical, Inc

FDA Device Registration & Listing · Hayward, CA, US · Registration 3010742884

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
3010742884
FEI Number
3010742884
Entity Name
Otsuka America Pharmaceutical, Inc
City/State/Country
Hayward, CA, US
Establishment Address
3956 Point Eden Way, Hayward, CA 94545, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OTSUKA AMERICA PHARMACEUTICAL INC (Owner Number: 9107159)
Owner / Operator Contact Address
2440 RESEARCH BLVD., --, Rockville, MD 20850, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251088
PMA Number
N/A

All Registered Proprietary Names

Otsuka Digital Feedback Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OZW Ingestible Event Marker General Hospital Class 2 880.6305 2025-07-10
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2025-07-10

Official Correspondent

Michael Fahmy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OTSUKA AMERICA PHARMACEUTICAL 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
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29
K910450 Medtech Industries, Inc. CARD GUARD-3000 ECG TELEPHONE ADAPTER 1991-05-07
K761318 Cambridge Instruments, Inc. 3038 OPTION B-COMPUT. TRANS. TERMINAL 1977-01-06
K972649 Reynolds Medical , Ltd. CARDIOCALL CARDIAC EVENT RECORDER 1997-12-04
K033410 Remote Diagnostic Technologies , Ltd. TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 2004-03-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010742884. Last updated year: 2026. Please use registration number 3010742884 when referencing this establishment in official correspondence.
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