Catalog Number

A10-1308-01

Brand Name

Vasomedical-Biox™ 1308 Ultra Compact 12- Channel ECG Holter Recorder

Version/Model Number

Model 1308

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111180

Product Code

DSH

Product Code Name

RECORDER, MAGNETIC TAPE, MEDICAL

Public Device Record Key

c4dd20eb-d044-4993-9e1b-cd5c69aa9d40

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-