FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINIMAP MODEL 810
K Number: K771981
·
Decision Jan 24, 1978
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
22
Review Days
98
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Basic Information
- Device Name
- MINIMAP MODEL 810
- K Number
- K771981
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Research
- Date Received
- October 18, 1977
- Decision Date
- January 24, 1978
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | 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 |
| K790328 | MODEL 1051, MONITOR | Mar 2, 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 |