FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSOUND MMI ULTRASOUND
K Number: K871442
·
Decision May 20, 1988
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
39
Review Days
403
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Basic Information
- Device Name
- BIOSOUND MMI ULTRASOUND
- K Number
- K871442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biosound, Inc.
- Date Received
- April 13, 1987
- Decision Date
- May 20, 1988
- Product Code
- JOP
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
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Other Clearances by Biosound, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | Jul 9, 1997 | Substantially Equivalent |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | Mar 31, 1997 | Substantially Equivalent |
| K963262 | ARTOSCAN M | Mar 28, 1997 | Substantially Equivalent |
| K963662 | GALILEO EVOKED POTENTIALRE | Feb 26, 1997 | Substantially Equivalent |
| K953716 | INTRACAVITY TRANSDUCERS | Apr 17, 1996 | Substantially Equivalent |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Apr 8, 1996 | Substantially Equivalent |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Mar 1, 1996 | Substantially Equivalent |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 1, 1996 | Substantially Equivalent |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Feb 12, 1996 | Substantially Equivalent |
| K953579 | TEE PROBE | Feb 2, 1996 | Substantially Equivalent |