Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French— 510(k) K193027
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K193027 for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French, Substantially Equivalent on 2020-04-02. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- Product code
- Code BZT
- Device class
- Class 2
- Regulation
- 21 CFR 868.1920
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Powell, TN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.