AEROMIST LT, MODEL HCS15004— 510(k) K031686
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K031686 for AEROMIST LT, MODEL HCS15004, Substantially Equivalent on 2004-01-21. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code BTI
- Device class
- Class 2
- Regulation
- 21 CFR 868.6250
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Adverse events under product code BTI
product code BTI- Death
- 25
- Malfunction
- 1,168
- Total
- 1,193
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.