FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEALTHCHECK THERM-STRIP
K Number: K863181
·
Decision Sep 11, 1986
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
13
Applicant Total
9
Review Days
23
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Basic Information
- Device Name
- HEALTHCHECK THERM-STRIP
- K Number
- K863181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Healthcheck Corp.
- Date Received
- August 19, 1986
- Decision Date
- September 11, 1986
- Product Code
- FQZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQZ | Thermometer, Clinical Color Change | FDA class 1 | General Hospital |
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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 |
| 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 |
| K850070 | HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 | Jan 22, 1985 | Substantially Equivalent |
| K844281 | PTK HEALTHCHECK PREGNANCY TEST KIT | Dec 10, 1984 | Substantially Equivalent |