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FDA 510(k)

AOT EXTERNAL COMPRESS DEVICE

K-Number: K854241 · 1986-03-03

ApplicantAdvanced Ortho-Technology, Inc.
Decision Date1986-03-03
Product CodeHWN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AOT EXTERNAL COMPRESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Ortho-Technology, Inc.. It received FDA 510(k) clearance on 1986-03-03 under 510(k) number K854241. The device is classified under product code HWN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOT EXTERNAL COMPRESS DEVICE?

AOT EXTERNAL COMPRESS DEVICE is a medical device that received FDA 510(k) clearance on 1986-03-03. The listed applicant is Advanced Ortho-Technology, Inc.. The 510(k) number is K854241.

When did AOT EXTERNAL COMPRESS DEVICE receive FDA 510(k) clearance?

AOT EXTERNAL COMPRESS DEVICE received FDA 510(k) clearance on 1986-03-03, under 510(k) number K854241.

Who is the listed applicant for AOT EXTERNAL COMPRESS DEVICE?

The FDA 510(k) record lists Advanced Ortho-Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOT EXTERNAL COMPRESS DEVICE?

The FDA product code for AOT EXTERNAL COMPRESS DEVICE is HWN.

Related Clinical Trials

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Other records listing Advanced Ortho-Technology, Inc. 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.

K861937AQUACEL SURGICAL PREP PADSK854344AQUACEL SURGICAL PREP PADS

Related Devices (Code: HWN)

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.

K792253ARICULATED TENSION DEVICE SYNTHES TENSynthes (Usa)K770349RIGID TEACHING ATTACHMENTRichard Wolf Medical Instruments Corp.K760970FLORIO CPC BANDRichard'S Medical Equip., Inc.

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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