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FDA 510(k)

STIMEL-03

K-Number: K130424 · 2013-07-11

ApplicantStimel, Ltd.
Decision Date2013-07-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STIMEL-03 is the device name listed in this FDA 510(k) record. The listed applicant is Stimel, Ltd.. It received FDA 510(k) clearance on 2013-07-11 under 510(k) number K130424. 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 STIMEL-03?

STIMEL-03 is a medical device that received FDA 510(k) clearance on 2013-07-11. The listed applicant is Stimel, Ltd.. The 510(k) number is K130424.

When did STIMEL-03 receive FDA 510(k) clearance?

STIMEL-03 received FDA 510(k) clearance on 2013-07-11, under 510(k) number K130424.

Who is the listed applicant for STIMEL-03?

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

What is the FDA product code for STIMEL-03?

The FDA product code for STIMEL-03 is IPF.

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Related Devices (Code: IPF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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