510(k) K183201
K183201 is an FDA 510(k) premarket notification submitted by Db Diagnostic Systems, Inc. for the device "Hearing Healthcare Pro". The FDA issued a decision of Substantially Equivalent on March 6, 2019. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Db Diagnostic Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2019
- Date Received
- November 19, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Auditory Impedance
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type