FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVIVO PULSE OXIMETER, MODEL 4500
K Number: K864730
·
Decision May 6, 1987
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
5
Review Days
153
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Basic Information
- Device Name
- INVIVO PULSE OXIMETER, MODEL 4500
- K Number
- K864730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Invivo Research Labs, Inc.
- Date Received
- December 4, 1986
- Decision Date
- May 6, 1987
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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