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FDA 510(k)

SINGLE USE MANOMETER

K-Number: K201666 · 2020-11-13

ApplicantFlexicare Medical Limited.
Decision Date2020-11-13
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SINGLE USE MANOMETER is a medical device manufactured by Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-11-13 under approval number K201666. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE MANOMETER?

SINGLE USE MANOMETER is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Flexicare Medical Limited.. The 510(k) number is K201666.

When was SINGLE USE MANOMETER approved by the FDA?

SINGLE USE MANOMETER received FDA 510(k) clearance on 2020-11-13, under approval number K201666.

What company makes SINGLE USE MANOMETER?

SINGLE USE MANOMETER is manufactured by Flexicare Medical Limited..

What is the FDA product code for SINGLE USE MANOMETER?

The FDA product code for SINGLE USE MANOMETER is CAP.

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Related Devices (Code: CAP)

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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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