Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005652389

FEI Number

3004846435

Entity Name

ATOM MEDICAL CORPORATION

City/State/Country

Sakura-ku, Saitama-shi, JP

Establishment Address

2-2-1, Dojo,, Sakura-ku, Saitama-shi 338-0835, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Atom Medical Corporation (Owner Number: 9042398)

Owner / Operator Contact Address

3-18-15, Hongo, Bunkyo-ku, JP-13 113-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103828

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHB	Timer, Apgar	General Hospital	Class 1	880.2930	2016-03-17
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2011-01-18
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2006-03-23
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2010-09-28
NZG	Bassinet, Hospital	General Hospital	Class 2	880.5145	2008-11-11
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2010-10-06
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2006-03-27
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2010-12-14
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2010-09-28
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2012-04-27
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2006-12-01
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2011-01-11
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2011-04-22
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2011-01-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-03-26
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2010-09-28
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2012-03-26
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2012-07-11
FPL	Incubator, Neonatal Transport	General Hospital	Class 2	880.5410	2013-05-30
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2011-01-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2015-01-27
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2011-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Atom Medical Corporation

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
K943360	Ohmeda Medical	OHIO CARE PLUS INCUBATOR	1994-09-29
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12
K881713	Gempco, Inc.	SPECIAL PROCEDURES BASE UNIT MODEL 500	1988-07-12
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

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3014220748	Datex-Ohmeda, Inc.	Wauwatosa, WI, US
3036470679	Datex-Ohmeda, Inc.	Waukesha, WI, US
3021559257	CAF MEDICAL SOLUTIONS INC	Hockley, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005652389. Last updated year: 2026. Please use registration number 3005652389 when referencing this establishment in official correspondence.