FDA 510(k)

PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251

K-Number: K014102 · 2002-02-21

Decision Date2002-02-21

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 is the device name listed in this FDA 510(k) record. The listed applicant is Atos Medical AB. It received FDA 510(k) clearance on 2002-02-21 under 510(k) number K014102. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251?

PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 is a medical device that received FDA 510(k) clearance on 2002-02-21. The listed applicant is Atos Medical AB. The 510(k) number is K014102.

When did PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 receive FDA 510(k) clearance?

PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 received FDA 510(k) clearance on 2002-02-21, under 510(k) number K014102.

Who is the listed applicant for PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251?

The FDA 510(k) record lists Atos Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251?

The FDA product code for PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 is JOH.

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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.