510(k) K891180
K891180 is an FDA 510(k) premarket notification submitted by Ingress Technologies, Inc. for the device "TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT". The FDA issued a decision of Substantially Equivalent on June 15, 1989. The device falls under product code DXP (Transducer, Vessel Occlusion), a Class II device regulated under 21 CFR 870.2890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1989
- Date Received
- March 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Vessel Occlusion
- Device Class
- Class II
- Regulation Number
- 870.2890
- Review Panel
- CV
- Submission Type