FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT FOLLOW-UP COMPUTER (PFC
K Number: K820402
·
Decision Mar 12, 1982
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
2
Review Days
28
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Basic Information
- Device Name
- PATIENT FOLLOW-UP COMPUTER (PFC
- K Number
- K820402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Systems, Inc.
- Date Received
- February 12, 1982
- Decision Date
- March 12, 1982
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983273 | XCT 2000 L PQCT BONE DENSITOMETER | Oct 29, 1998 | Substantially Equivalent |