FDA 510(k)

ELF

K-Number: K853433 · 1985-11-29

Decision Date1985-11-29

Product CodeBTY

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ELF is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Respiratory. It received FDA 510(k) clearance on 1985-11-29 under 510(k) number K853433. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELF?

ELF is a medical device that received FDA 510(k) clearance on 1985-11-29. The listed applicant is Cardio-Respiratory. The 510(k) number is K853433.

When did ELF receive FDA 510(k) clearance?

ELF received FDA 510(k) clearance on 1985-11-29, under 510(k) number K853433.

Who is the listed applicant for ELF?

The FDA 510(k) record lists Cardio-Respiratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELF?

The FDA product code for ELF is BTY.

Related PubMed Literature

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.

PMID: 41105489Medical device shelf-life and recalls: navigating healthcare challenges.Expert review of medical devices ()

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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.