Foley Catheter with Temperature Sensor— 510(k) K200757
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K200757 for Foley Catheter with Temperature Sensor, Substantially Equivalent on 2020-10-15. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- Product code
- Code EYC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- 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.