510(k) K923830
K923830 is an FDA 510(k) premarket notification submitted by Xomed-Treace, Inc. for the device "XOMED-TREACE ALPHASCOPE". The FDA issued a decision of Substantially Equivalent on November 9, 1992. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Xomed-Treace, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1992
- Date Received
- July 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Otoscope
- Device Class
- Class I
- Regulation Number
- 874.4770
- Review Panel
- EN
- Submission Type