FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI-TRAK
K Number: K864889
·
Decision Mar 6, 1987
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
5
Review Days
84
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Basic Information
- Device Name
- OMNI-TRAK
- K Number
- K864889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Invivo Research Labs, Inc.
- Date Received
- December 12, 1986
- Decision Date
- March 6, 1987
- Product Code
- DSB
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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