Who else makes this device?

Name: Atom Infant Incubator 101 AC120V w/o O2 Controller Unit
Brand: Atom Infant Incubator 101 AC120V w/o O2 Controller Unit

General Hospital › TherapeuticIncubator, Neonatal

Atom Infant Incubator 101 AC120V W/o O2 Controller Unit

Catalogue number 61607, listed by Atom Medical Corporation, Japan, under Incubator, Neonatal. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

5recalls on this code

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FMZ
Manufacturer	City	Province	Registered as	Device types
Amphenol (Changzhou) Connector Systems Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	4
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Atom Infant Incubator 101 AC120V w/o O2 Controller Unit
Listed by	Atom Medical Corporation, Japan
FDA product code	FMZ
Device type	Incubator, Neonatal
Device class	Class 2
Regulation	21 CFR 880.5400
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2019-01-29 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 20 to 30 °C
Sizes	Depth 68 cm; width 107 cm

Catalogue Numbers

Catalogue numbers for Atom Infant Incubator 101 AC120V w/o O2 Controller Unit
Catalogue number	Size	Status
61607	Depth 68 cm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tarry Probes	Tarry Medical Products, Inc.	7
Midas Rex MR8	Medtronic Powered Surgical Solutions	6
Airlife	AirLife Finland Oy	6
AirLife	Carefusion Finland 320 Oy	5
Multi-Link™	AirLife Finland Oy	3
Access Medical Probes	Tarry Medical Products, Inc.	3
Advanced Neonatal Incubator	Advanced Instrumentations, Inc.	2
Babyleo TN500	Drägerwerk AG & Co. KGaA	2
Isolette® 8000 plus	Draeger Medical Systems, Inc.	2
Isolette 8000 Infant Incubator	Draeger Medical Systems, Inc.	1
Skin Temp Probe, 5mm O.D.(Y)	Atom Medical Corporation	1
Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set)	Atom Medical Corporation	1

Showing 12 of 41. All products under Incubator, Neonatal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K102226	2011-01-04
K102279	2010-12-29
K102710	2010-12-22
K061856	2006-09-28
K021809	2002-07-18

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-05-01	Class II	Device Design	There is a potential for the device’s canopy to move unintentionally when using the incubator mode or radiant warmer mode.	377 units	2013-01-31
2011-08-23	Not classified	Device Design	The caster with lock on the incubator or infant warmer may become loose or break.	105 units	2013-09-09
2011-08-23	Not classified	Device Design	The caster with lock on the incubator may become loose or break.		2013-09-09
2011-08-23	Not classified	Device Design	The caster with lock on the incubator may become loose or break.	32 units	2013-09-09
2011-08-23	Not classified	Device Design	The caster with lock on the radiant-warming open type incubator may become loose or break.	133 units	2013-09-09

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.