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FDA 510(k)

Orfit Aerial Couchtop

K-Number: K200282 · 2020-04-08

ApplicantOrfit Industries NV
Decision Date2020-04-08
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Orfit Aerial Couchtop is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K200282. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orfit Aerial Couchtop?

Orfit Aerial Couchtop is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Orfit Industries NV. The 510(k) number is K200282.

When did Orfit Aerial Couchtop receive FDA 510(k) clearance?

Orfit Aerial Couchtop received FDA 510(k) clearance on 2020-04-08, under 510(k) number K200282.

Who is the listed applicant for Orfit Aerial Couchtop?

The FDA 510(k) record lists Orfit Industries NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orfit Aerial Couchtop?

The FDA product code for Orfit Aerial Couchtop is LHN.

Other records listing Orfit Industries NV as applicant

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Related Devices (Code: LHN)

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.

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