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FDA 510(k)

PENTAX Medical Auto Leakage Tester SHA-P6

K-Number: K212201 · 2021-10-01

ApplicantPentax of America, Inc.
Decision Date2021-10-01
Product CodePCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Auto Leakage Tester SHA-P6 is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K212201. The device is classified under product code PCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Auto Leakage Tester SHA-P6?

PENTAX Medical Auto Leakage Tester SHA-P6 is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Pentax of America, Inc.. The 510(k) number is K212201.

When was PENTAX Medical Auto Leakage Tester SHA-P6 approved by the FDA?

PENTAX Medical Auto Leakage Tester SHA-P6 received FDA 510(k) clearance on 2021-10-01, under approval number K212201.

What company makes PENTAX Medical Auto Leakage Tester SHA-P6?

PENTAX Medical Auto Leakage Tester SHA-P6 is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Auto Leakage Tester SHA-P6?

The FDA product code for PENTAX Medical Auto Leakage Tester SHA-P6 is PCV.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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