510(k) K891180
- Device
- Transesophageal Ultrasound Accessories Kit
- Applicant
- INGRESS TECHNOLOGIES, INC.
- 510(k) number
- K891180
- Product code
- DXP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-15
- Date received
- 1989-03-06
- Regulation
- 870.2890
- Classification name
- Transducer, Vessel Occlusion
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHANE H ABOWITT
- Address
- 3702 E. Roeser Rd., Suite 27 P.O. Box 62404 Phoenix AZ US 85082 85082
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812639 | UNICUFF | Frontier Products | 1981-10-02 |