FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION WATCHGUARD
K Number: K902104
·
Decision Oct 25, 1990
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
22
Applicant Total
1
Review Days
170
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Basic Information
- Device Name
- ORION WATCHGUARD
- K Number
- K902104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Orion Industries
- Date Received
- May 8, 1990
- Decision Date
- October 25, 1990
- 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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