Catalog Number

-

Brand Name

Summit to Sea

Version/Model Number

The Dive Hyperbaric Chamber

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072757

Product Code

CBF

Product Code Name

Chamber, Hyperbaric

Public Device Record Key

04bc26ec-17f3-4b61-a91e-12d4d3203a04

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-