FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABCOM 1 CARDIAC OUTPUT MONITOR
K Number: K870857
·
Decision Nov 16, 1987
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
3
Review Days
258
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Basic Information
- Device Name
- ABCOM 1 CARDIAC OUTPUT MONITOR
- K Number
- K870857
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Biometrics, Inc.
- Date Received
- March 3, 1987
- Decision Date
- November 16, 1987
- 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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