FDA.reportPublic FDA data

Electronic Blood Pressure Monitor

Primary DI
06948423816218
Brand
Electronic Blood Pressure Monitor
Company
Shenzhen Pango Electronic Co., Ltd.
Model
PG-800B18
Device description
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200716000Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.2020-12-04DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948423816218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948423816218069484238162186948423816218

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
529222127
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948423808763Infrared ThermometerPG-IRT16032020-04-17
06948423808817Infrared ThermometerPG-IRT16012020-04-17
06948423808824Infrared ThermometerPG-IRT16022020-04-17
06948423800002Electronic Blood Pressure MonitorPG-800B2016-11-23
06948423800019Electronic Blood Pressure MonitorPG-800BD2016-11-23
06948423800026Electronic Blood Pressure MonitorPG-800B-12016-11-23
06948423800033Electronic Blood Pressure MonitorPG-800BD-12016-11-23
06948423800040Electronic Blood Pressure MonitorPG-800B32016-11-23
06948423800057Electronic Blood Pressure MonitorPG-800B42016-11-23
06948423800064Electronic Blood Pressure MonitorPG-800B4D2016-11-23
06948423800071Electronic Blood Pressure MonitorPG-800B52016-11-23
06948423800088Electronic Blood Pressure MonitorPG-800B5-12016-11-23
06948423800095Electronic Blood Pressure MonitorPG-800B62016-11-23
06948423800101Electronic Blood Pressure MonitorPG-800B6D2016-11-23
06948423800118Electronic Blood Pressure MonitorPG-800B6-12016-11-23
06948423800125Electronic Blood Pressure MonitorPG-800B6-22016-11-23
06948423800132Electronic Blood Pressure MonitorPG-800B72016-11-23
06948423800149Electronic Blood Pressure MonitorPG-800B82016-11-23
06948423800156Electronic Blood Pressure MonitorPG-800B92016-11-23
06948423800163Electronic Blood Pressure MonitorPG-800B102016-11-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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