TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX— 510(k) K030299
Substantially EquivalentOriental System Technology, Inc.
FDA 510(k) clearance K030299 for TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX, Substantially Equivalent on 2003-02-25. Applicant: Oriental System Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Oriental System Technology, 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
- Special
- Location
- Great Neck, NY, US
Recent devices under product code FLL
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- K250470 — Ear Thermometer (3 models)
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Oriental System Technology, Inc.
view all- K042202 — TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
- K010235 — TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
- K001008 — TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
- K992601 — TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
- K984497 — TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.