FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPERATURE FUNCTION BLOCK
K Number: K810173
·
Decision Feb 2, 1981
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
69
Review Days
11
Basic Information
- Device Name
- TEMPERATURE FUNCTION BLOCK
- K Number
- K810173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- HONEYWELL, INC.
- Date Received
- January 22, 1981
- Decision Date
- February 2, 1981
- Product Code
- FLL
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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|---|---|---|---|
| K902230 | COLORADO COLOR IMAGING RECORDER | Jun 19, 1990 | Substantially Equivalent |
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| K855125 | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K851888 | APM DISPOS. BLOOD PRESSURE TRANSDUCER | Aug 6, 1985 | Substantially Equivalent |
| K851496 | ECG MONITOR MODEL RM102 | Jul 24, 1985 | Substantially Equivalent |
| K850794 | PATIENT MONITOR MODEL RM-300 | Apr 18, 1985 | Substantially Equivalent |
| K851092 | PORTABLE DEFIBRILLATOR/MONITOR ED 425 | Apr 10, 1985 | Substantially Equivalent |
| K834530 | EXTENSION BOX EB200 | Jun 1, 1984 | Substantially Equivalent |
| K834282 | ULTRA IMAGER 2000 | Apr 23, 1984 | Substantially Equivalent |