Who else makes this device?

Name: DL900 Norav Encrypted
Brand: DL900 Norav Encrypted

Cardiovascular › MonitoringElectrocardiograph, Ambulatory (Without Analysis)

DL900 Norav Encrypted

Catalogue number 900-0570-24, listed by Braemar Manufacturing, LLC, United States, under Electrocardiograph, Ambulatory (Without Analysis). 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

2recalls on this code

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MWJ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC	Shanghai	Shanghai	Specification developer	6
DM Systems (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	1

Record

Regulatory record for DL900 Norav Encrypted
Listed by	Braemar Manufacturing, LLC, United States
FDA product code	MWJ
Device type	Electrocardiograph, Ambulatory (Without Analysis)
Device class	Class 2
Regulation	21 CFR 870.2800
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2017-02-11
Record revised	2025-08-04 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Distribution end date	2025-07-11

Catalogue Numbers

Catalogue numbers for DL900 Norav Encrypted
Catalogue number	Size	Status
900-0570-24		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Spacelabs Healthcare	Spacelabs Healthcare (Washington), Inc	60
Welch Allyn, Inc.	Welch Allyn, Inc.	58
Norav NR Series	Norav Medical Inc.	56
Eclipse Pro	Spacelabs Healthcare (Washington), Inc	25
Seer 1000	Getemed Medizin- UND Informationstechnik AG	15
Seer 1000 ECG Cable	Getemed Medizin- UND Informationstechnik AG	12
ECG Cable for Seer 1000	Getemed Medizin- UND Informationstechnik AG	12
Seer	Suzuken Co., Ltd.	12
H12+	Mortara Instrument, Inc.	10
Lifecard	Spacelabs Healthcare (Washington), Inc	10
H3+ Patient Cable	Mortara Instrument, Inc.	10
Spiderview	Microport CRM SRL	9

Showing 12 of 107. All products under Electrocardiograph, Ambulatory (Without Analysis)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130294	2013-10-16

Recalls

2 of these are 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
2020-01-22	Class II	Software design	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in	10582	2022-05-27
2020-01-22	Class II	Software design	An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in	10582	2022-05-27

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.