LOUISVILLE LABS OXYGEN HEAD TENT— 510(k) K955535
Substantially EquivalentLouisville Laboratories, Inc.
FDA 510(k) clearance K955535 for LOUISVILLE LABS OXYGEN HEAD TENT, Substantially Equivalent on 1996-07-01. Applicant: Louisville Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Louisville Laboratories, Inc.
- Product code
- Code CBF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5470
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, KY, US
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Adverse events under product code CBF
product code CBF- Death
- 6
- Total
- 6
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.