510(k) K923072
K923072 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "HANDTYMP". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1993
- Date Received
- June 25, 1992
- 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