FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
K Number: K903414
·
Decision Sep 19, 1990
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
77
Applicant Total
6
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
- K Number
- K903414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Echo Ultrasound
- Date Received
- July 30, 1990
- Decision Date
- September 19, 1990
- Product Code
- DXK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXK | Echocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXK), ordered by most recent decision date.
Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
FDA 510(k)
FDA Class 2
·Cardiovascular
IN-VISION IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
9750 ATHENA ETHERNET OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESSORY TO GENESIS III (GCFM)
FDA 510(k)
FDA Class 2
·Cardiovascular
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Echo Ultrasound
| K Number | Device Name | ||
|---|---|---|---|
| K924054 | PHONOCARDIOGRAPH | Jan 22, 1993 | Substantially Equivalent |
| K893225 | COUPLANT WARMING DEVICE | Oct 12, 1989 | Substantially Equivalent |
| K872519 | STERILIZED OMNI GEL | Aug 3, 1987 | Substantially Equivalent |
| K844034 | SONOCARE | Jan 23, 1985 | Substantially Equivalent |
| K844120 | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | Jan 23, 1985 | Substantially Equivalent |