FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DeRoyal Temperature Monitoring Probe
K Number: K200631
·
Decision Dec 23, 2020
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
91
Review Days
288
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Basic Information
- Device Name
- DeRoyal Temperature Monitoring Probe
- K Number
- K200631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deroyal Industries, Inc.
- Date Received
- March 10, 2020
- Decision Date
- December 23, 2020
- 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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Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
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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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·General Hospital
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