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FDA 510(k)

ISI SELF-SUPPORTING ARM

K-Number: K925005 · 1993-04-29

ApplicantInstrumentation Specialties, Inc.
Decision Date1993-04-29
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISI SELF-SUPPORTING ARM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Specialties, Inc.. It received FDA 510(k) clearance on 1993-04-29 under 510(k) number K925005. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISI SELF-SUPPORTING ARM?

ISI SELF-SUPPORTING ARM is a medical device that received FDA 510(k) clearance on 1993-04-29. The listed applicant is Instrumentation Specialties, Inc.. The 510(k) number is K925005.

When did ISI SELF-SUPPORTING ARM receive FDA 510(k) clearance?

ISI SELF-SUPPORTING ARM received FDA 510(k) clearance on 1993-04-29, under 510(k) number K925005.

Who is the listed applicant for ISI SELF-SUPPORTING ARM?

The FDA 510(k) record lists Instrumentation Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISI SELF-SUPPORTING ARM?

The FDA product code for ISI SELF-SUPPORTING ARM is BWN.

Related Clinical Trials

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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Other records listing Instrumentation Specialties, 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.

K881101K ORTHOPEDIC TABLE

Related Devices (Code: BWN)

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.

K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K935441INFINITECH BREATH EZInfinitech, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment GroupK902865BAUMER SURGICAL TABLESds Dental, Inc.K884558IOP ADJUSTABLE STIRRUPMend Technologies, 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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