FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
K Number: K844120
·
Decision Jan 23, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
6
Review Days
92
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Basic Information
- Device Name
- ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
- K Number
- K844120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1925
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Echo Ultrasound
- Date Received
- October 23, 1984
- Decision Date
- January 23, 1985
- Product Code
- GXX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXX | Block, Test, Ultrasonic Scanner Calibration | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXX), ordered by most recent decision date.
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
FDA 510(k)
FDA Class 1
·Neurology
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Echo Ultrasound
| K Number | Device Name | ||
|---|---|---|---|
| K924054 | PHONOCARDIOGRAPH | Jan 22, 1993 | Substantially Equivalent |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Sep 19, 1990 | 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 |