FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K Number: K864908
·
Decision Mar 27, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
35
Applicant Total
42
Review Days
102
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Basic Information
- Device Name
- DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
- K Number
- K864908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Diasonics, Inc.
- Date Received
- December 15, 1986
- Decision Date
- March 27, 1987
- Product Code
- HGL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGL), ordered by most recent decision date.
ULTRASOUND TRANSDUCER, MODEL US917
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ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
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ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
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EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
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ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Diasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | Jan 2, 1997 | Substantially Equivalent |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K911435 | CPA/3.5 MHZ PROBE | Sep 11, 1992 | Substantially Equivalent |
| K905200 | SACA, 3.5 MHZ PROBE | Apr 2, 1992 | Substantially Equivalent |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | Mar 2, 1992 | Substantially Equivalent |
| K903984 | CW DOPPLER/4.5 MHZ | Jun 14, 1991 | Substantially Equivalent |
| K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P | Jan 22, 1990 | Substantially Equivalent |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | Oct 27, 1989 | Substantially Equivalent |
| K894290 | ACCESS TM | Sep 7, 1989 | Substantially Equivalent |
| K893881 | ACCESS TM | Jun 23, 1989 | Substantially Equivalent |