Multiplace Hyperbaric Oxygen Treatment Chamber DL8213

GUDID B718DL82130

A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT),

FINK ENGINEERING PTY LTD

Hyperbaric chamber, stationary

• Primary Device ID: B718DL82130
• NIH Device Record Key: dce4426a-e9bd-4121-a5e2-c2b5d15b896e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multiplace Hyperbaric Oxygen Treatment Chamber
• Version Model Number: DL8
• Catalog Number: DL8213
• Company DUNS: 748668373
• Company Name: FINK ENGINEERING PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61754384900
• Email: support@fink.com.au
• Phone: +61754384900
• Email: support@fink.com.au

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B718DL82130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031649

FDA Product Code

• CBF: Chamber, Hyperbaric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-14

On-Brand Devices [Multiplace Hyperbaric Oxygen Treatment Chamber]

• B718DL82130: A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient i
• B718DL82030: A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient i