FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASOUND GEL
K Number: K850290
·
Decision Apr 18, 1985
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
5
Review Days
84
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Basic Information
- Device Name
- ULTRASOUND GEL
- K Number
- K850290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Litton Datamedix
- Date Received
- January 24, 1985
- Decision Date
- April 18, 1985
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Litton Datamedix
| K Number | Device Name | ||
|---|---|---|---|
| K853599 | LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI | Mar 21, 1986 | Substantially Equivalent |
| K842497 | SERVOMED OXYMONITO SMK 363 | Oct 4, 1984 | Substantially Equivalent |
| K842235 | SERVOCARD DEFIBRILLATOR SCP-851 | Aug 27, 1984 | Substantially Equivalent |
| K842312 | SERVOCARD SCP-840 | Aug 27, 1984 | Substantially Equivalent |