FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUORO PLUS
K Number: K861279
·
Decision Jun 16, 1986
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
17
Review Days
70
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Basic Information
- Device Name
- FLUORO PLUS
- K Number
- K861279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Advantage Medical Systems, Inc.
- Date Received
- April 7, 1986
- Decision Date
- June 16, 1986
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Advantage Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K861556 | MODIFIED FETAL MONITOR MODEL FM-2 | Jul 7, 1986 | Substantially Equivalent |
| K861455 | MODEL DT-102 DATA TELEPHONE TRANSMITTER | May 30, 1986 | Substantially Equivalent for Some Indications |
| K852518 | MODIFICATION FETAL MONITOR MODEL FM-2 | Jul 5, 1985 | Substantially Equivalent |
| K844724 | FETAL TELEMETRY SYSTEM | May 1, 1985 | Substantially Equivalent |
| K842462 | HOLTER SCREENING MONITOR HS-221 | Sep 11, 1984 | Substantially Equivalent |
| K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P | Jun 19, 1984 | Substantially Equivalent |
| K832849 | FETAL MONITOR #FM-2 | Oct 4, 1983 | Substantially Equivalent |