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FDA 510(k)

MODEL PMT850

K-Number: K070931 · 2007-05-24

ApplicantPromedtek, Inc.
Decision Date2007-05-24
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL PMT850 is the device name listed in this FDA 510(k) record. The listed applicant is Promedtek, Inc.. It received FDA 510(k) clearance on 2007-05-24 under 510(k) number K070931. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL PMT850?

MODEL PMT850 is a medical device that received FDA 510(k) clearance on 2007-05-24. The listed applicant is Promedtek, Inc.. The 510(k) number is K070931.

When did MODEL PMT850 receive FDA 510(k) clearance?

MODEL PMT850 received FDA 510(k) clearance on 2007-05-24, under 510(k) number K070931.

Who is the listed applicant for MODEL PMT850?

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

What is the FDA product code for MODEL PMT850?

The FDA product code for MODEL PMT850 is ILX.

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Other records listing Promedtek, Inc. 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.

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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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