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FDA 510(k)

ERGOTEST 40 & 45

K-Number: K843855 · 1984-11-27

ApplicantErich Jaeger, Inc.
Decision Date1984-11-27
Product CodeISP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ERGOTEST 40 & 45 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 1984-11-27 under 510(k) number K843855. The device is classified under product code ISP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGOTEST 40 & 45?

ERGOTEST 40 & 45 is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Erich Jaeger, Inc.. The 510(k) number is K843855.

When did ERGOTEST 40 & 45 receive FDA 510(k) clearance?

ERGOTEST 40 & 45 received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843855.

Who is the listed applicant for ERGOTEST 40 & 45?

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 ERGOTEST 40 & 45?

The FDA product code for ERGOTEST 40 & 45 is ISP.

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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.

K000396APNOESCREEN PRO, ALPHA SCREEN PROK972419TOENNIES NEUROSCREEN SYSTEMK960078ASTHMA MONITORK933839MASTER SCREEN PNUEMOK932744FLOWSCREENK853443ALVEO-DIFFUSION TEST

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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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