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FDA 510(k)

ZERO-G(TM) GEL/FOAM MATTRESS TOPPER

K-Number: K911843 · 1991-05-30

ApplicantSteridyne Corp.
Decision Date1991-05-30
Product CodeKIC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ZERO-G(TM) GEL/FOAM MATTRESS TOPPER is the device name listed in this FDA 510(k) record. The listed applicant is Steridyne Corp.. It received FDA 510(k) clearance on 1991-05-30 under 510(k) number K911843. The device is classified under product code KIC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZERO-G(TM) GEL/FOAM MATTRESS TOPPER?

ZERO-G(TM) GEL/FOAM MATTRESS TOPPER is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Steridyne Corp.. The 510(k) number is K911843.

When did ZERO-G(TM) GEL/FOAM MATTRESS TOPPER receive FDA 510(k) clearance?

ZERO-G(TM) GEL/FOAM MATTRESS TOPPER received FDA 510(k) clearance on 1991-05-30, under 510(k) number K911843.

Who is the listed applicant for ZERO-G(TM) GEL/FOAM MATTRESS TOPPER?

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

What is the FDA product code for ZERO-G(TM) GEL/FOAM MATTRESS TOPPER?

The FDA product code for ZERO-G(TM) GEL/FOAM MATTRESS TOPPER is KIC.

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 Steridyne Corp. 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.

K925352CLEAN CUFF BLOOD PRESSURE CUFF LINERK911269MERCURY AND GLASS FEVER THERMOMETERK842120ZERO-GK821314FEVER METERK801458WINTER HEAD DRESSING

Related Devices (Code: KIC)

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.

K960189GEL-T CUSHIONSpan-America Medical Systems, Inc.K953352PROTEAM CUSHIONIskra.MedK954117CUSTOMCARE SEATING SYSTEMSpan-America Medical Systems, Inc.K950085MULTICURE(R) S GEL PADMultigestion (Deutschland) GmbHK945667MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHIONMicos Medical SystemsK941858GEL CUSHIONHollister, 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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