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FDA 510(k)

CASSETTE READER

K-Number: K811253 · 1981-07-10

ApplicantAmerican Edwards Laboratories
Decision Date1981-07-10
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CASSETTE READER is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811253. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASSETTE READER?

CASSETTE READER is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is American Edwards Laboratories. The 510(k) number is K811253.

When did CASSETTE READER receive FDA 510(k) clearance?

CASSETTE READER received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811253.

Who is the listed applicant for CASSETTE READER?

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

What is the FDA product code for CASSETTE READER?

The FDA product code for CASSETTE READER is DSH.

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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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