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FDA 510(k)

SLEEP SYSTEM FOR CLINICS & RESEARCH

K-Number: K955841 · 1997-03-11

ApplicantCompumedics Ptd , Ltd.
Decision Date1997-03-11
Product CodeMNR
Advisory CommitteeAN
DecisionUnknown

Device Summary

SLEEP SYSTEM FOR CLINICS & RESEARCH is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Ptd , Ltd.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K955841. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SLEEP SYSTEM FOR CLINICS & RESEARCH?

SLEEP SYSTEM FOR CLINICS & RESEARCH is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Compumedics Ptd , Ltd.. The 510(k) number is K955841.

When did SLEEP SYSTEM FOR CLINICS & RESEARCH receive FDA 510(k) clearance?

SLEEP SYSTEM FOR CLINICS & RESEARCH received FDA 510(k) clearance on 1997-03-11, under 510(k) number K955841.

Who is the listed applicant for SLEEP SYSTEM FOR CLINICS & RESEARCH?

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

What is the FDA product code for SLEEP SYSTEM FOR CLINICS & RESEARCH?

The FDA product code for SLEEP SYSTEM FOR CLINICS & RESEARCH 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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