Who else makes this device?

Name: Norav 1200 Series PC-ECG
Brand: Norav 1200 Series PC-ECG

Cardiovascular › MonitoringElectrocardiograph, Ambulatory, With Analysis Algorithm

Norav 1200 Series PC-ECG

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB or SD Card Reader (for DL800/900…

Registry build 21.09.26

Norav 1200 Series PC-ECG Software Kit with the following Option(s): – Ambulatory ECG Monitoring (Holter) Analysis – Support for data transfer via USB or SD Card Reader (for DL800/900 recorders) The Kit includes: Software Protection Key – “HASP-Key” Software on Installation Medium (CD or USB-Stick).

2manufacturers in China registered for this device type

6catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Hebei (1), Shanghai (1).

Chinese manufacturers registered for FDA product code MLO
Manufacturer	City	Province	Registered as	Device types
Contec Medical Systems Co., Ltd.	Qinhuangdao	Hebei	Manufacturer	22
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC	Shanghai	Shanghai	Specification developer	6

Record

Regulatory record for Norav 1200 Series PC-ECG
Listed by	Norav Medical Inc., United States
FDA product code	MLO
Device type	Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class	Class 2
Regulation	21 CFR 870.2800
Establishment	Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2019-10-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Norav 1200 Series PC-ECG
Catalogue number	Size	Status
SW NH300 Ana to 301		In distribution
SW NH300-N		In distribution
SW NH301-4		In distribution
SW NH301-2		In distribution
SW NH301-N		In distribution
SW NH301-3		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HScribe	Mortara Instrument, Inc.	55
Welch Allyn, Inc.	Welch Allyn, Inc.	41
Millennia Software	Braemar Manufacturing, LLC	18
Patient Cable	Global Instrumentation, LLC	13
Modality Manager	Mortara Instrument, Inc.	10
Matrix Holter System	Global Instrumentation, LLC	5
GI Holter System	Global Instrumentation, LLC	5
Cardiospy ECG Holter System	Labtech Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság	4
WA Holter System	Global Instrumentation, LLC	3
Contec	Contec Medical Systems Co., Ltd.	3
Scribe	Mortara Instrument, Inc.	2
Pouch	Global Instrumentation, LLC	2

Showing 12 of 33. All products under Electrocardiograph, Ambulatory, With Analysis Algorithm

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111487	2011-11-10
K012712	2002-05-08

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.