FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TMA TEMPERATURE MONITOR
K Number: K852825
·
Decision Dec 3, 1985
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
57
Review Days
155
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Basic Information
- Device Name
- TMA TEMPERATURE MONITOR
- K Number
- K852825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ferguson Medical
- Date Received
- July 1, 1985
- Decision Date
- December 3, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
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Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
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YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
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Infrared Thermometer
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|---|---|---|---|
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| K963794 | PUNCTURENEEDLE | Mar 19, 1998 | Substantially Equivalent |
| K962615 | TUMORLOCALIZER MRI | Mar 19, 1998 | Substantially Equivalent |
| K971813 | EMBLA | Jan 16, 1998 | Substantially Equivalent |
| K972217 | ORTHOPEDIC SCREW SYSTEM | Nov 20, 1997 | Substantially Equivalent |
| K972219 | ORTHOPEDIC PLATE SYSTEM | Nov 20, 1997 | Substantially Equivalent |
| K970819 | TARGOBEAM | Jul 14, 1997 | Substantially Equivalent |
| K970280 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES | May 22, 1997 | Substantially Equivalent |
| K970258 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES | May 22, 1997 | Substantially Equivalent |
| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |