FDA.reportPublic FDA data

Handheld Pulse Monitor

Primary DI
06932562310058
Brand
Handheld Pulse Monitor
Company
Guangdong Biolight Meditech Co., Ltd.
Model
M800
Device description
The monitor is indicated for spot checking of functional arterial SpO2(BLT-SpO2), and pulse rate of patient.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101694000HANDHELD PULSE OXIMETER MODEL M800Guangdong Biolight Meditech Co., Ltd.2010-09-08DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932562310058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932562310058069325623100586932562310058

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530120146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932562310355Fingertip Pluse OximeterM70D2024-03-29
06932562310362handheld monitorM8002024-03-29
06932562310263Fetal monitorF302018-04-09
06932562310270Fetal monitorF502018-04-09
06932562310287Fetal monitorF802018-04-09
06932562310294Fetal monitorF902018-04-09
06932562310317 Fingertip Pulse OximeterM502019-08-28
06932562310324 Fingertip Pulse OximeterM50L2019-08-28
06932562310348Fingertip Pulse OximeterM50A2021-06-28
06932562310331patient monitorM90002020-08-10
06932562310300Vital Signs MonitorV92019-07-03
06932562310003Fingertip Pluse OximterM702016-09-07
06932562310010Fingertip Pluse OximeterM70A2016-09-20
06932562310027Fingertip Pluse OximeterM70C2016-09-13
06932562310065Handheld Pulse OximeterM7002016-09-22
06932562310089Patient MonitorQ52016-09-22
06932562310096Patient MonitorQ52016-09-22
06932562310102Patient MonitorM85002016-09-22
06932562310119Patient MonitorM95002016-09-22
06932562310126Patient MonitorV62016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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