SURETEMP PLUS— 510(k) K030580
Substantially EquivalentWelch Allyn, Inc.
FDA 510(k) clearance K030580 for SURETEMP PLUS, Substantially Equivalent on 2003-05-06. Applicant: Welch Allyn, Inc.. Device class: 2.
Clearance details
- Applicant
- Welch Allyn, 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
- San Diego, CA, US
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More clearances from Welch Allyn, 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 →
Recalls naming K030580
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 K030580.
Data sourced from openFDA. This site is unofficial and independent of the FDA.