FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K Number: K954847
·
Decision May 22, 1996
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
22
Applicant Total
1
Review Days
212
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Basic Information
- Device Name
- DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
- K Number
- K954847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ocg Systems, Inc.
- Date Received
- October 23, 1995
- Decision Date
- May 22, 1996
- 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 |
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