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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 the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-11-13 under 510(k) 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. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K201666.

When did SINGLE USE MANOMETER receive FDA 510(k) clearance?

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

Who is the listed applicant for SINGLE USE MANOMETER?

The FDA 510(k) record lists Flexicare Medical Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE USE MANOMETER?

The FDA product code for SINGLE USE MANOMETER is CAP.

Other records listing Flexicare Medical Limited. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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