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FDA 510(k)

SLEEPFLO, MODEL 101501

K-Number: K020607 · 2002-08-30

ApplicantBiomec, Inc.
Decision Date2002-08-30
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPFLO, MODEL 101501 is the device name listed in this FDA 510(k) record. The listed applicant is Biomec, Inc.. It received FDA 510(k) clearance on 2002-08-30 under 510(k) number K020607. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPFLO, MODEL 101501?

SLEEPFLO, MODEL 101501 is a medical device that received FDA 510(k) clearance on 2002-08-30. The listed applicant is Biomec, Inc.. The 510(k) number is K020607.

When did SLEEPFLO, MODEL 101501 receive FDA 510(k) clearance?

SLEEPFLO, MODEL 101501 received FDA 510(k) clearance on 2002-08-30, under 510(k) number K020607.

Who is the listed applicant for SLEEPFLO, MODEL 101501?

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

What is the FDA product code for SLEEPFLO, MODEL 101501?

The FDA product code for SLEEPFLO, MODEL 101501 is MNR.

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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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