FDA.reportPublic FDA data

MTS

Primary DI
00869667000408
Brand
MTS
Company
MEDICAL TEST SUPPLY
Model
OX-610A
Catalog number
OX610A
Device description
The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (Spo2) and pulse rate (PR). It is motion tolerant and can be used during exercise and other daily activities.
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063641000PC-60, NON-INVASIVEPULSE OXIMETERShenzhen Creative Industry Co., Ltd.2007-07-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869667000408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869667000408008696670004088696670004080869667000408

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

Contacts#

Phone, Email table
PhoneEmail
1-855-270-5357customerservice@medicaltestsupply.com

Regulatory Flags#

DUNS number
064063916
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869667000415MTSOX-400AOX400A2017-11-09
00869667000422MTSOX-300AOX300A2017-11-13
00869667000439MTSOX-200AOX200A2017-11-13
00869667000446MTSOX-550APOX550AP2017-11-13
00869667000453MTSOX-500AOX500A2017-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979934380042ConcordChangsha Brilliant Easesyn Technology Co.,Ltd.OCH2026-05-26
06979934380059ConcordChangsha Brilliant Easesyn Technology Co.,Ltd.OCH2026-05-26
06938395500321CONCORDShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-28
06938395500314AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-27
06938395500284AccuMedShenzhen Hexin ZONDAN Medical Equipment Co., LtdOCH2026-04-15
08719481723408iProvènSevenground Trading B.V.OCH2026-03-09
06973912940525 simplicare IMDKOCH2025-12-03
06951740540377THERMOBIOShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-10-18
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-09-29
06951740540360NOVAShenzhen Jumper Medical Equipment Co.,Ltd.OCH2025-08-07
00846841091599mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092701mibestBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00846841092947ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OCH2025-07-22
00850043916000ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916024ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850043916031ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006543InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00851697006659InnovoEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007513ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007698ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007704ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007728ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007780ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007803ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007810ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007827ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007919ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00856964007964ZacurateEINSTEIN ASSOCIATES LLCOCH2025-01-28
00850000967311CMI HealthCMI HEALTH INC.OCH2025-01-17
06941900601314Pulse OximeterShenzhen Creative Industry Co., Ltd.OCH2024-12-27