PENTAX Medical Auto Leakage Tester SHA-P6— 510(k) K212201
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K212201 for PENTAX Medical Auto Leakage Tester SHA-P6, Substantially Equivalent on 2021-10-01. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code PCV
- 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
Recent devices under product code PCV
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Data sourced from openFDA. This site is unofficial and independent of the FDA.