PENTAX Medical Gas/Water Feeding Valve OE-B14— 510(k) K232249
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K232249 for PENTAX Medical Gas/Water Feeding Valve OE-B14, Substantially Equivalent on 2023-12-01. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code ODC
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.