FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BIOMA 5000
K Number: K880036
·
Decision Mar 7, 1988
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
3
Review Days
62
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Basic Information
- Device Name
- BIOMA 5000
- K Number
- K880036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- E.B.S., Inc.
- Date Received
- January 5, 1988
- Decision Date
- March 7, 1988
- Product Code
- DRG
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
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