Who else makes this device?

Name: Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR
Brand: Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR

General Hospital › TherapeuticIncubator, Neonatal Transport

Filter Element E(10 Pcs/pkg) for V-808/V-850TR/V-80TR

Catalogue number 60317, listed by Atom Medical Corporation, Japan, under Incubator, Neonatal Transport. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

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

Record

Regulatory record for Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR
Listed by	Atom Medical Corporation, Japan
FDA product code	FPL
Device type	Incubator, Neonatal Transport
Device class	Class 2
Regulation	21 CFR 880.5410
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2024-09-19 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR
Catalogue number	Size	Per pack	Status
60317		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
185A+ Infant Incubator	International Biomedical, Ltd.	2
Voyager Infant Transport Incubator	International Biomedical, Ltd.	2
NxtGen Infant Transport Incubator	International Biomedical, Ltd.	2
Reusable Skin Temperature Probes	Flexicare Medical Ltd.	2
LMT nomag® IC 1.5	LMT Medical Systems Gmbh	2
Aviator Transport Incubator	International Biomedical, Ltd.	2
LMT nomag® IC 3.0	LMT Medical Systems Gmbh	2
Disposable Skin Temperature Probes	Flexicare Medical Ltd.	2
Advanced Transport Incubator	Advanced Instrumentations, Inc.	1
V-808 Main Unit Only(120 V)	Atom Medical Corporation	1
Oxygen Sensor For V-808	Atom Medical Corporation	1
Isolette TI500 Transport Incubator	Draeger Medical Systems, Inc.	1

Showing 12 of 18. All products under Incubator, Neonatal Transport

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K123937	2013-05-23
K061071	2006-08-29

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.