Duns Number:198227881
Device Description: MicroTymp 4 Portable Tympanometer System with Printer, Includes MicroTymp 4 Hand Set, Char MicroTymp 4 Portable Tympanometer System with Printer, Includes MicroTymp 4 Hand Set, Charging Cradle, Power Supply, Ear Tip Starter Kit, 4-volume test cavity, Probe Tip Cleaning Kit, Serial Printer Cable, USB Data Cable, MPT-II Printer Kit, USB Thumb Drive with DFUs and TympView Software
Catalog Number
93700
Brand Name
Welch Allyn, Inc.
Version/Model Number
901033
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ETY
Product Code Name
Tester, auditory impedance
Public Device Record Key
93e7410c-ed56-4256-8ad7-1a4f4ee9ce78
Public Version Date
June 28, 2022
Public Version Number
2
DI Record Publish Date
May 06, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |