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FDA 510(k)

FLEXI-LITE

K-Number: K101262 · 2010-06-10

ApplicantPressure-Tech, Inc.
Decision Date2010-06-10
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXI-LITE is the device name listed in this FDA 510(k) record. The listed applicant is Pressure-Tech, Inc.. It received FDA 510(k) clearance on 2010-06-10 under 510(k) number K101262. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXI-LITE?

FLEXI-LITE is a medical device that received FDA 510(k) clearance on 2010-06-10. The listed applicant is Pressure-Tech, Inc.. The 510(k) number is K101262.

When did FLEXI-LITE receive FDA 510(k) clearance?

FLEXI-LITE received FDA 510(k) clearance on 2010-06-10, under 510(k) number K101262.

Who is the listed applicant for FLEXI-LITE?

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

What is the FDA product code for FLEXI-LITE?

The FDA product code for FLEXI-LITE is CBF.

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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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