FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
K Number: K850070
·
Decision Jan 22, 1985
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
9
Review Days
18
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Basic Information
- Device Name
- HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
- K Number
- K850070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Healthcheck Corp.
- Date Received
- January 4, 1985
- Decision Date
- January 22, 1985
- 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 Healthcheck Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K884489 | C&T PREGNANCY TEST KIT | Mar 8, 1989 | Substantially Equivalent |
| K874818 | TENSTAR | Sep 28, 1988 | Substantially Equivalent |
| K881003 | DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 | May 18, 1988 | Substantially Equivalent |
| K863181 | HEALTHCHECK THERM-STRIP | Sep 11, 1986 | Substantially Equivalent |
| K861946 | PTK PLUS. HOME PREGNANCY TEST | Jun 16, 1986 | Substantially Equivalent |
| K860287 | PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 | Apr 28, 1986 | Substantially Equivalent |
| K851379 | HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 | Apr 12, 1985 | Substantially Equivalent |
| K844281 | PTK HEALTHCHECK PREGNANCY TEST KIT | Dec 10, 1984 | Substantially Equivalent |