510(k) K192100
K192100 is an FDA 510(k) premarket notification submitted by Meditrina, Inc. for the device "Aveta Disposable Hysteroscope". The FDA issued a decision of Substantially Equivalent on December 19, 2019. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Meditrina, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2019
- Date Received
- August 5, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type