510(k) K943721
K943721 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "OTOVIEW TELESCOPIC OTOSCOPES". The FDA issued a decision of Substantially Equivalent on November 18, 1994. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1994
- Date Received
- August 1, 1994
- 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