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FDA 510(k)

POWER INFUSER, MODEL M100B-3A

K-Number: K090736 · 2009-05-20

ApplicantZOLL Medical Corporation
Decision Date2009-05-20
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWER INFUSER, MODEL M100B-3A is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2009-05-20 under 510(k) number K090736. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWER INFUSER, MODEL M100B-3A?

POWER INFUSER, MODEL M100B-3A is a medical device that received FDA 510(k) clearance on 2009-05-20. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K090736.

When did POWER INFUSER, MODEL M100B-3A receive FDA 510(k) clearance?

POWER INFUSER, MODEL M100B-3A received FDA 510(k) clearance on 2009-05-20, under 510(k) number K090736.

Who is the listed applicant for POWER INFUSER, MODEL M100B-3A?

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

What is the FDA product code for POWER INFUSER, MODEL M100B-3A?

The FDA product code for POWER INFUSER, MODEL M100B-3A is FRN.

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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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