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FDA 510(k)

ManaFlow

K-Number: K200353 · 2020-08-06

ApplicantManamed, Inc.
Decision Date2020-08-06
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ManaFlow is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K200353. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ManaFlow?

ManaFlow is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Manamed, Inc.. The 510(k) number is K200353.

When did ManaFlow receive FDA 510(k) clearance?

ManaFlow received FDA 510(k) clearance on 2020-08-06, under 510(k) number K200353.

Who is the listed applicant for ManaFlow?

The FDA 510(k) record lists Manamed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ManaFlow?

The FDA product code for ManaFlow is JOW.

Other records listing Manamed, Inc. 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.

View all 9 devices →

Related Devices (Code: JOW)

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.

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.