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FDA 510(k)

SMART BAG MO

K-Number: K021328 · 2003-06-26

ApplicantO-Two Systems International, Inc.
Decision Date2003-06-26
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMART BAG MO is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems International, Inc.. It received FDA 510(k) clearance on 2003-06-26 under 510(k) number K021328. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART BAG MO?

SMART BAG MO is a medical device that received FDA 510(k) clearance on 2003-06-26. The listed applicant is O-Two Systems International, Inc.. The 510(k) number is K021328.

When did SMART BAG MO receive FDA 510(k) clearance?

SMART BAG MO received FDA 510(k) clearance on 2003-06-26, under 510(k) number K021328.

Who is the listed applicant for SMART BAG MO?

The FDA 510(k) record lists O-Two Systems International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART BAG MO?

The FDA product code for SMART BAG MO is BTM.

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Related Devices (Code: BTM)

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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