FDA 510(k)

BODY-JET

K-Number: K082025 · 2008-08-13

Decision Date2008-08-13

Product CodeQPB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BODY-JET is the device name listed in this FDA 510(k) record. The listed applicant is Human Med AG. It received FDA 510(k) clearance on 2008-08-13 under 510(k) number K082025. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODY-JET?

BODY-JET is a medical device that received FDA 510(k) clearance on 2008-08-13. The listed applicant is Human Med AG. The 510(k) number is K082025.

When did BODY-JET receive FDA 510(k) clearance?

BODY-JET received FDA 510(k) clearance on 2008-08-13, under 510(k) number K082025.

Who is the listed applicant for BODY-JET?

The FDA 510(k) record lists Human Med AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODY-JET?

The FDA product code for BODY-JET is QPB.

Other records listing Human Med AG 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.

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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.