Resonance 4300104100

GUDID 08051597160099

SCREENING MIDDLE EAR ANALYZER

M.R.S. SRL

Impedance audiometer

• Primary Device ID: 08051597160099
• NIH Device Record Key: cd2a91f4-a38f-4f21-86cb-1d08dc750783
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resonance
• Version Model Number: R16M
• Catalog Number: 4300104100
• Company DUNS: 514071869
• Company Name: M.R.S. SRL
• 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: false
• 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	08051597160099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031978

FDA Product Code

• ETY: Tester, Auditory Impedance

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: 2025-09-09
• Device Publish Date: 2025-09-01

On-Brand Devices [Resonance]

• 08051597160099: SCREENING MIDDLE EAR ANALYZER
• 08051597160051: SCREENING COMBINED MIDDLE EAR ANALYZER
• 08051597160549: USB VIDEO OTOSCOPE COMPLETE WITH CRADLE
• 08051597160501: USB VIDEO OTOSCOPE
• 08051597160297: USB VIDEO OTOSCOPE BULK PACKAGE