FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONO TRAK T.M.
K Number: K790037
·
Decision Jan 26, 1979
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
19
Review Days
18
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Basic Information
- Device Name
- SONO TRAK T.M.
- K Number
- K790037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Narco Air-Shields
- Date Received
- January 8, 1979
- Decision Date
- January 26, 1979
- 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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|---|---|---|---|
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| K810474 | PROBE COVER | Mar 31, 1981 | Substantially Equivalent |
| K802800 | NARCO AIR-SHEILDS SYS. 100 MONITOR SYS | Nov 24, 1980 | Substantially Equivalent |
| K802126 | ISOLETTE INCUBATOR C-100 | Sep 26, 1980 | Substantially Equivalent |
| K792592 | AMBU UNIVERSAL SUCTION PUMP | Jan 11, 1980 | Substantially Equivalent |
| K792499 | AMBU PAEDI ANAESTHESIA SYSTEM | Dec 19, 1979 | Substantially Equivalent |
| K792117 | AIR-SHIELDS HEART RATE MONITOR | Nov 13, 1979 | Substantially Equivalent |
| K792118 | AIR-SHIELDS RESUSCITATORS | Nov 13, 1979 | Substantially Equivalent |
| K790552 | AS7 & AS8 MONITORS | May 1, 1979 | Substantially Equivalent |