510(k) K183691
K183691 is an FDA 510(k) premarket notification submitted by Pentax Of America, Inc. for the device "PENTAX Medical ENT Video Imaging System". The FDA issued a decision of Substantially Equivalent on Jun 12, 2019. The device falls under product code EOB (Nasopharyngoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4760. Pentax Of America, Inc. has 43 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 12, 2019
- Date Received
- Dec 31, 2018
- 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
- 510(k)
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).