510(k) K163412
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2017
- Date Received
- December 5, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laryngoscope, Rigid
- Device Class
- Class I
- Regulation Number
- 868.5540
- Review Panel
- AN
- Submission Type