Catalog Number

-

Brand Name

Zmachine

Version/Model Number

Synergy

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

K172986

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

5fc78ddc-6f20-43eb-b29c-945d67994fb9

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-