FDA 510(k)

BODY BOOT

K-Number: K940723 · 1994-09-06

Decision Date1994-09-06

Product CodeLYU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BODY BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Mark-Clark. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K940723. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODY BOOT?

BODY BOOT is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Mark-Clark. The 510(k) number is K940723.

When did BODY BOOT receive FDA 510(k) clearance?

BODY BOOT received FDA 510(k) clearance on 1994-09-06, under 510(k) number K940723.

Who is the listed applicant for BODY BOOT?

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

What is the FDA product code for BODY BOOT?

The FDA product code for BODY BOOT is LYU.

Other records listing Mark-Clark 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.

K961884CATH CADDIE

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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.