Maico

GUDID 04260176120520

MAICO Diagnostics GmbH

Evoked-potential audiometer

• Primary Device ID: 04260176120520
• NIH Device Record Key: a4828600-4874-4f69-ba58-338a6373204a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maico
• Version Model Number: MB11 Classic
• Company DUNS: 344863550
• Company Name: MAICO Diagnostics GmbH
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260176120520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082035

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [Maico]

• 04260176121190: RA660
• 04260176121114: MA 28
• 04260176126935: Pilot Test
• 04260176121961: MA 33
• 04260176120902: MA 42
• 04260176120865: MA 27
• 04260176120858: MA 1
• 04260176120834: easyTymp
• 04260176120704: MA 41
• 04260176120520: MB11 Classic
• 04260176120513: MB 11 BERAphone
• 04260176120377: MA 25
• 04260176120148: ERO SCAN
• 04260176129431: easyTone
• 04260176127444: MA 42