FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BIOMA 3500
K Number: K872370
·
Decision Dec 7, 1987
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
3
Review Days
171
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIOMA 3500
- K Number
- K872370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- E.B.S., Inc.
- Date Received
- June 19, 1987
- Decision Date
- December 7, 1987
- Product Code
- KRC
- 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 |
|---|---|---|---|
| KRC | Tester, Electrode, Surface, Electrocardiographic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRC), ordered by most recent decision date.
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
FDA 510(k)
FDA Class 2
·Cardiovascular
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
SKIN PREP ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPEDANCE/8200 MONITOR-MODEL 8300
FDA 510(k)
FDA Class 2
·Cardiovascular
CONDUCTANCE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
Z VIEW METER MODEL 300
FDA 510(k)
FDA Class 2
·Cardiovascular