FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALOG PMS-8
K Number: K845051
·
Decision May 15, 1985
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
10
Applicant Total
4
Review Days
147
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Basic Information
- Device Name
- VITALOG PMS-8
- K Number
- K845051
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2710
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vitalog Corp.
- Date Received
- December 19, 1984
- Decision Date
- May 15, 1985
- Product Code
- DPZ
- 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 |
|---|---|---|---|
| DPZ | Oximeter, Ear | FDA class 2 | Cardiovascular |
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