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FDA 510(k)

I-SPOUSE

K-Number: K953089 · 1995-10-16

ApplicantProducts For Medicine
Decision Date1995-10-16
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I-SPOUSE is the device name listed in this FDA 510(k) record. The listed applicant is Products For Medicine. It received FDA 510(k) clearance on 1995-10-16 under 510(k) number K953089. 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 I-SPOUSE?

I-SPOUSE is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Products For Medicine. The 510(k) number is K953089.

When did I-SPOUSE receive FDA 510(k) clearance?

I-SPOUSE received FDA 510(k) clearance on 1995-10-16, under 510(k) number K953089.

Who is the listed applicant for I-SPOUSE?

The FDA 510(k) record lists Products For Medicine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-SPOUSE?

The FDA product code for I-SPOUSE is LYU.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Products For Medicine 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.

K963227WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175K955510X6000D SILENT SUN LIGHT SOURCEK951704NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATIONK951703TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORSK883658I-SPOSE EYE SHIELD

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., 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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