510(k) K031978
K031978 is an FDA 510(k) premarket notification submitted by Amplaid for the device "AMPLAID A756 SCREENING ADMITTANCE METER". The FDA issued a decision of Substantially Equivalent on July 21, 2003. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2003
- Date Received
- June 26, 2003
- Clearance Type
- Special
- 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