EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR— 510(k) K925791
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K925791 for EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR, Substantially Equivalent on 1994-02-25. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Powell, TN, US
Recent devices under product code FLL
view all- K253162 — Temperature probes (5 models)
- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K250470 — Ear Thermometer (3 models)
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Deroyal Industries, Inc.
view all- K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
- K230233 — Prospera Spectruum Negative Pressure Wound Therapy System
- K200631 — DeRoyal Temperature Monitoring Probe
- K200757 — Foley Catheter with Temperature Sensor
- K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K925791
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925791.
Data sourced from openFDA. This site is unofficial and independent of the FDA.