FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K Number: K934638
·
Decision May 13, 1994
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
18
Review Days
231
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Basic Information
- Device Name
- REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
- K Number
- K934638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Koven Technology, Inc.
- Date Received
- September 24, 1993
- Decision Date
- May 13, 1994
- Product Code
- JOP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
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