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FDA 510(k)

PRESSUREGUARD IV

K-Number: K972486 · 1998-02-20

ApplicantSpan-America Medical Systems, Inc.
Decision Date1998-02-20
Product CodeIKZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRESSUREGUARD IV is the device name listed in this FDA 510(k) record. The listed applicant is Span-America Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-02-20 under 510(k) number K972486. The device is classified under product code IKZ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREGUARD IV?

PRESSUREGUARD IV is a medical device that received FDA 510(k) clearance on 1998-02-20. The listed applicant is Span-America Medical Systems, Inc.. The 510(k) number is K972486.

When did PRESSUREGUARD IV receive FDA 510(k) clearance?

PRESSUREGUARD IV received FDA 510(k) clearance on 1998-02-20, under 510(k) number K972486.

Who is the listed applicant for PRESSUREGUARD IV?

The FDA 510(k) record lists Span-America Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSUREGUARD IV?

The FDA product code for PRESSUREGUARD IV is IKZ.

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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 Span-America Medical Systems, 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.

K973169PRESSURE GUARD SITE SELECT (A)K960188PRESSUREGUARD: SELECTCAREK961502LUBRICATING JELLY, LOW VISCOSITYK961159POWERED LOW AIR LOSS MATTRESS SYSTEMK960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEMK960189GEL-T CUSHION

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Related Devices (Code: IKZ)

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.

K972111RUMORS DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMGaymar Industries, Inc.K954671THE FREEDOM BEDProbed Medical Technologies, Inc.K950756PULMONEX DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K950681MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPYInvacare Corp.K933964THE CRADLEThe Primal Energy Research Foundation

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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