FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1051, MONITOR
K Number: K790328
·
Decision Mar 2, 1979
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
22
Review Days
14
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Basic Information
- Device Name
- MODEL 1051, MONITOR
- K Number
- K790328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Research
- Date Received
- February 16, 1979
- Decision Date
- March 2, 1979
- 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 Applied Medical Research
| K Number | Device Name | ||
|---|---|---|---|
| K800025 | DINAMAP RESEARCH MONITOR 1245 | Feb 1, 1980 | Substantially Equivalent |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Sep 4, 1979 | Substantially Equivalent |
| K791159 | DINAMAP MODEL 855 | Jul 30, 1979 | Substantially Equivalent |
| K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 | May 14, 1979 | Substantially Equivalent |
| K782073 | DINAMAP MODELS 1160 AND 1165 | Feb 23, 1979 | Substantially Equivalent |
| K781053 | DINAMAP MODEL 846 | Sep 7, 1978 | Substantially Equivalent |
| K781064 | DINAMAP MODEL 848 | Sep 7, 1978 | Substantially Equivalent |
| K781311 | ELECTRODE, NEEDLE, CFM | Aug 21, 1978 | Substantially Equivalent |
| K780754 | NEONATAL MONITOR | Jun 14, 1978 | Substantially Equivalent |
| K780759 | MODEL 902 STAND | May 19, 1978 | Substantially Equivalent |