FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ADR ULTRASOUND MC2 LARGE CART
K Number: K828049
·
Decision Sep 29, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
29
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Basic Information
- Device Name
- ADR ULTRASOUND MC2 LARGE CART
- K Number
- K828049
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Adr Ultrasound
- Date Received
- August 31, 1982
- Decision Date
- September 29, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Adr Ultrasound
| K Number | Device Name | ||
|---|---|---|---|
| K840408 | LINEAR ARRAY TRANSDUCER OR SCANHEAD | Apr 25, 1984 | Substantially Equivalent |
| K834141 | ULTRASOUND SCAN HEAD 3.5 MHZ | Apr 20, 1984 | Substantially Equivalent |
| K833224 | BIFOCAL 3.0MHZ | Nov 29, 1983 | Substantially Equivalent |
| K828051 | ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC | Sep 29, 1982 | Substantially Equivalent |
| K828053 | ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER | Sep 29, 1982 | Substantially Equivalent |
| K828050 | ADR ULTRASOUND MODEL 4000 L | Sep 29, 1982 | Substantially Equivalent |
| K813543 | ADR ULTRASOUND MODELS 4000S & 4000S/L | Feb 24, 1982 | Substantially Equivalent |
| K812301 | VARIABLE FOCUS 3.5 MHZ TRANSDUCER | Nov 16, 1981 | Substantially Equivalent |
| K792446 | ADR REAL-TIME SECTOR SCANNER | Jan 9, 1980 | Substantially Equivalent |