510(k) K041853
K041853 is an FDA 510(k) premarket notification submitted by Tympany, Inc. for the device "OTOGRAM". The FDA issued a decision of Substantially Equivalent on September 3, 2004. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Tympany, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2004
- Date Received
- July 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Hearing Aid / Earphone And Analysis Systems
- Device Class
- Class II
- Regulation Number
- 874.3310
- Review Panel
- EN
- Submission Type