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FDA 510(k)

CLINICAL DATA APNEA DETECTOR

K-Number: K821721 · 1982-07-13

ApplicantClinical Data, Inc.
Decision Date1982-07-13
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CLINICAL DATA APNEA DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821721. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL DATA APNEA DETECTOR?

CLINICAL DATA APNEA DETECTOR is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Clinical Data, Inc.. The 510(k) number is K821721.

When did CLINICAL DATA APNEA DETECTOR receive FDA 510(k) clearance?

CLINICAL DATA APNEA DETECTOR received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821721.

Who is the listed applicant for CLINICAL DATA APNEA DETECTOR?

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

What is the FDA product code for CLINICAL DATA APNEA DETECTOR?

The FDA product code for CLINICAL DATA APNEA DETECTOR is FLS.

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Related Devices (Code: FLS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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