Otogram

Basic Information

• Brand Name: Otogram
• Primary DI: M737S3000R1
• Version / Model: S3000R
• Company Name: Ototronix, LLC
• Labeler DUNS: 833067478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7f062438-448e-4949-9382-36323de699dd

Device Description

Otogram S3000R

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41187	Tone audiometer, automated	An electroacoustic device designed to be used in a clinical setting to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. A computer or microprocessor in the device automatically produces tones that sweep the audiometric scale and controls tone intensity and frequency. The device also records the patient's responses and may display calculated hearing thresholds. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M737S3000R1	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K070118	000