FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOCO TRANSDUCER
K Number: K952579
·
Decision Aug 4, 1995
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
22
Applicant Total
6
Review Days
60
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Basic Information
- Device Name
- TOCO TRANSDUCER
- K Number
- K952579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scientific Device Manufacturer, LLC
- Date Received
- June 5, 1995
- Decision Date
- August 4, 1995
- Product Code
- HFM
- 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 |
|---|---|---|---|
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFM), ordered by most recent decision date.
KOALA TOCO
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·Obstetrics/Gynecology
FEATHERLITE AQUA TOCODYNAMOMETER
FDA 510(k)
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·Obstetrics/Gynecology
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TOCO LITE, MODEL TD-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Scientific Device Manufacturer, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K960764 | SAFE-CATH | Apr 24, 1997 | Substantially Equivalent |
| K960431 | PRESSURE STOPCOCK/MANIFOLD | Oct 29, 1996 | Substantially Equivalent |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | Oct 15, 1996 | Substantially Equivalent |
| K960430 | CONTROL SYRINGE | Aug 6, 1996 | Substantially Equivalent |
| K960917 | PERCUGLIDE | Jul 2, 1996 | Substantially Equivalent |