TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
FDA 510(k) clearance K891180 · decided 1989-06-15
Clearance details
- K-number
- K891180
- Device name
- TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
- Applicant
- Ingress Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-06
- Decision date
- 1989-06-15
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- DXP
- Device class
- 2
- Regulation number
- 870.2890
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNICUFF (K812639) | Frontier Products | 1981-10-02 |
Recalls involving this device
No recalls on record reference this clearance.