510(k) K080622
K080622 is an FDA 510(k) premarket notification submitted by Optim, Inc. for the device "ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105". The FDA issued a decision of Substantially Equivalent on April 2, 2008. The device falls under product code EOB (Nasopharyngoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4760. Optim, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2008
- Date Received
- March 5, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nasopharyngoscope (Flexible Or Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4760
- Review Panel
- EN
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).