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FDA 510(k)

RESUSCI FLOW; RESUSCI FLOW 104

K-Number: K102542 · 2011-04-06

Decision Date2011-04-06
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUSCI FLOW; RESUSCI FLOW 104 is the device name listed in this FDA 510(k) record. The listed applicant is Atom Medical Corporation. It received FDA 510(k) clearance on 2011-04-06 under 510(k) number K102542. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUSCI FLOW; RESUSCI FLOW 104?

RESUSCI FLOW; RESUSCI FLOW 104 is a medical device that received FDA 510(k) clearance on 2011-04-06. The listed applicant is Atom Medical Corporation. The 510(k) number is K102542.

When did RESUSCI FLOW; RESUSCI FLOW 104 receive FDA 510(k) clearance?

RESUSCI FLOW; RESUSCI FLOW 104 received FDA 510(k) clearance on 2011-04-06, under 510(k) number K102542.

Who is the listed applicant for RESUSCI FLOW; RESUSCI FLOW 104?

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

What is the FDA product code for RESUSCI FLOW; RESUSCI FLOW 104?

The FDA product code for RESUSCI FLOW; RESUSCI FLOW 104 is BTL.

Related Clinical Trials

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.

Other records listing Atom Medical Corporation 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 10 devices →

Related Devices (Code: BTL)

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.

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