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FDA 510(k)

APNOESCREEN PRO, ALPHA SCREEN PRO

K-Number: K000396 · 2000-12-27

ApplicantErich Jaeger, Inc.
Decision Date2000-12-27
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNOESCREEN PRO, ALPHA SCREEN PRO is the device name listed in this FDA 510(k) record. The listed applicant is Erich Jaeger, Inc.. It received FDA 510(k) clearance on 2000-12-27 under 510(k) number K000396. 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 APNOESCREEN PRO, ALPHA SCREEN PRO?

APNOESCREEN PRO, ALPHA SCREEN PRO is a medical device that received FDA 510(k) clearance on 2000-12-27. The listed applicant is Erich Jaeger, Inc.. The 510(k) number is K000396.

When did APNOESCREEN PRO, ALPHA SCREEN PRO receive FDA 510(k) clearance?

APNOESCREEN PRO, ALPHA SCREEN PRO received FDA 510(k) clearance on 2000-12-27, under 510(k) number K000396.

Who is the listed applicant for APNOESCREEN PRO, ALPHA SCREEN PRO?

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

What is the FDA product code for APNOESCREEN PRO, ALPHA SCREEN PRO?

The FDA product code for APNOESCREEN PRO, ALPHA SCREEN PRO is MNR.

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Other records listing Erich Jaeger, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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