FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MGD-3
K Number: K800095
·
Decision Feb 11, 1980
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- MGD-3
- K Number
- K800095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kt Medical, Inc.
- Date Received
- January 14, 1980
- Decision Date
- February 11, 1980
- Product Code
- KNG
- 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 |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Fetal Doppler U8-25, U9-25
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Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
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Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
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Fetal Doppler
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Other Clearances by Kt Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800653 | SINVISION LINEAR ARRAY REAL TIME | Jul 21, 1980 | Substantially Equivalent |
| K800652 | MODEL E03 ECHO-OPTHALMOSCOPE | May 14, 1980 | Substantially Equivalent |
| K800101 | 4200 ME ECHOENCEPHALOGRAPH | May 2, 1980 | Substantially Equivalent |
| K800092 | COMBISON COMPUTER | Apr 8, 1980 | Substantially Equivalent |
| K800100 | 7200 MA ECHO-OPHTHALMOSCOPE | Feb 21, 1980 | Substantially Equivalent |
| K800099 | INTRACULA II | Feb 21, 1980 | Substantially Equivalent |
| K800098 | MINIFETON 200 | Feb 11, 1980 | Substantially Equivalent |
| K800094 | COMBISON 200 & COMBISON 202 | Feb 11, 1980 | Substantially Equivalent |
| K800093 | TRANSDUCER | Feb 11, 1980 | Substantially Equivalent |
| K800091 | COMBISON 100-MODEL 100 & 110 | Feb 11, 1980 | Substantially Equivalent |