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FDA 510(k)

SCREENMATE

K-Number: K853409 · 1986-02-05

ApplicantErich Jaeger, Inc.
Decision Date1986-02-05
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SCREENMATE 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 1986-02-05 under 510(k) number K853409. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREENMATE?

SCREENMATE is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Erich Jaeger, Inc.. The 510(k) number is K853409.

When did SCREENMATE receive FDA 510(k) clearance?

SCREENMATE received FDA 510(k) clearance on 1986-02-05, under 510(k) number K853409.

Who is the listed applicant for SCREENMATE?

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 SCREENMATE?

The FDA product code for SCREENMATE is BZG.

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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 MONITORK932744FLOWSCREENK933839MASTER SCREEN PNUEMOK853443ALVEO-DIFFUSION TEST

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Related Devices (Code: BZG)

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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