510(k) K211894
K211894 is an FDA 510(k) premarket notification submitted by Disa Medinotec for the device "Trachealator". The FDA issued a decision of Substantially Equivalent on November 24, 2021. The device falls under product code KTI (Bronchoscope Accessory), a Class II device regulated under 21 CFR 874.4680. Disa Medinotec has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2021
- Date Received
- June 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bronchoscope Accessory
- Device Class
- Class II
- Regulation Number
- 874.4680
- 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).