Gsi 37 Auto Tymp
FDA 510(k) K911095 · Lucas Grason-Stadler, Inc.
510(k) numberK911095
Submission
- Device name
- Gsi 37 Auto Tymp
- Applicant
- Lucas Grason-Stadler, Inc.
Littleton, MA, US - Received
- March 13, 1991
- Decision date
- March 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
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| K133013 | Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus…ETY · Traditional | Inventis S.R.L. | 01/24/2014SE |
| K121847 | TitanETY · Traditional | Interacoustics A/S | 11/29/2012SE |
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…ETY · Traditional | Interacoustics AS | 04/09/2009SE |
| K081841 | Amplivox Otowave 102 Hand Held Portable TympanometerETY · Traditional | Amplivox, Ltd. | 07/16/2008SE |
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Questions and answers
When was Gsi 37 Auto Tymp cleared by the FDA?
Gsi 37 Auto Tymp (K911095) received a 510(k) decision of Substantially Equivalent on March 29, 1991, 16 days after the submission was received.
What is the product code of K911095?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.