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FDA 510(k)

MAXEMS, MODELS 1000 AND 2000

K-Number: K091248 · 2009-11-30

ApplicantBio Protech, Inc.
Decision Date2009-11-30
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MAXEMS, MODELS 1000 AND 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2009-11-30 under 510(k) number K091248. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXEMS, MODELS 1000 AND 2000?

MAXEMS, MODELS 1000 AND 2000 is a medical device that received FDA 510(k) clearance on 2009-11-30. The listed applicant is Bio Protech, Inc.. The 510(k) number is K091248.

When did MAXEMS, MODELS 1000 AND 2000 receive FDA 510(k) clearance?

MAXEMS, MODELS 1000 AND 2000 received FDA 510(k) clearance on 2009-11-30, under 510(k) number K091248.

Who is the listed applicant for MAXEMS, MODELS 1000 AND 2000?

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

What is the FDA product code for MAXEMS, MODELS 1000 AND 2000?

The FDA product code for MAXEMS, MODELS 1000 AND 2000 is IPF.

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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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