FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BP800, 850 1000
K Number: K841095
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
14
Review Days
164
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Basic Information
- Device Name
- BP800, 850 1000
- K Number
- K841095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Associated Mills, Inc.
- Date Received
- March 13, 1984
- Decision Date
- August 24, 1984
- 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 Associated Mills, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901459 | DS60 TOOTHBRUSH SANITIZER | Sep 17, 1990 | Substantially Equivalent |
| K872327 | WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 | Sep 4, 1987 | Substantially Equivalent |
| K871661 | WH150 ROOM HUMIDIFIER | Jun 15, 1987 | Substantially Equivalent |
| K862041 | WM10, WM20, WM30 POWER MASSAGER | Jun 17, 1986 | Substantially Equivalent |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Jun 5, 1986 | Substantially Equivalent |
| K844396 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 | Apr 18, 1985 | Substantially Equivalent |
| K844397 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 | Apr 18, 1985 | Substantially Equivalent |
| K850363 | POLLENEX DIGITAL THERMOMETER T-225 | Feb 15, 1985 | Substantially Equivalent |
| K850362 | POLLENEX DIGITAL THERMOMETER T-125 | Feb 15, 1985 | Substantially Equivalent |
| K841100 | HP-20, 30, 40, 50 & 60 | Mar 23, 1984 | Substantially Equivalent |