ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE— 510(k) K912742
Substantially EquivalentSpacelabs, Inc.
FDA 510(k) clearance K912742 for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE, Substantially Equivalent on 1992-04-20. Applicant: Spacelabs, Inc.. Device class: 2.
Clearance details
- Applicant
- Spacelabs, 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
- Redmond, WA, US
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Spacelabs, Inc.
view allAdverse 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.