510(k) K853863
K853863 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 310 IMPEDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 18, 1985. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Virtual Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1985
- Date Received
- September 17, 1985
- 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