Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012243264

FEI Number

3012243264

Entity Name

SMART CHOICE MEDICAL INC.

City/State/Country

Sylmar, CA, US

Establishment Address

15823 Monte St, Unit E105, Sylmar, CA 91342, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Smart Choice Medical Inc (Owner Number: 10051227)

Owner / Operator Contact Address

15823 Monte St, Unit E105, Sylmar, CA 91342, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Respirator, surgical GARMENT, PROTECTIVE, FOR INCONTINENCE BEDDING, DISPOSABLE, MEDICAL ACCESSORY, SURGICAL APPAREL Oximeter COVER, MATTRESS (MEDICAL PURPOSES)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-02-19
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2017-01-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-04-21
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2018-06-16

Official Correspondent

Grikor Kavoukjian

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smart Choice Medical 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3020623413	NITTA S.A.	Bogota, CO
3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3041850200	RISKWISE SUPPLIES LLC	Lorton, VA, US
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3010141571	Xiantao Zhongyi Safety & Protection Products Co.,Ltd.	Xiantao City Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012243264. Last updated year: 2026. Please use registration number 3012243264 when referencing this establishment in official correspondence.