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FDA 510(k)

ERGO DIAGNOSTIC CARD

K-Number: K834145 · 1984-03-16

ApplicantAmerican Ergo Systems
Decision Date1984-03-16
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ERGO DIAGNOSTIC CARD is the device name listed in this FDA 510(k) record. The listed applicant is American Ergo Systems. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834145. The device is classified under product code HOX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGO DIAGNOSTIC CARD?

ERGO DIAGNOSTIC CARD is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is American Ergo Systems. The 510(k) number is K834145.

When did ERGO DIAGNOSTIC CARD receive FDA 510(k) clearance?

ERGO DIAGNOSTIC CARD received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834145.

Who is the listed applicant for ERGO DIAGNOSTIC CARD?

The FDA 510(k) record lists American Ergo Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERGO DIAGNOSTIC CARD?

The FDA product code for ERGO DIAGNOSTIC CARD is HOX.

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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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