510(k) K070118
K070118 is an FDA 510(k) premarket notification submitted by Tympany, Inc. for the device "OTOGRAM, CA3350". The FDA issued a decision of Substantially Equivalent on March 7, 2007. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Tympany, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2007
- Date Received
- January 12, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type