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FDA 510(k)

PRESSUREGUARD: SELECTCARE

K-Number: K960188 · 1996-10-02

ApplicantSpan-America Medical Systems, Inc.
Decision Date1996-10-02
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSUREGUARD: SELECTCARE 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 1996-10-02 under 510(k) number K960188. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREGUARD: SELECTCARE?

PRESSUREGUARD: SELECTCARE is a medical device that received FDA 510(k) clearance on 1996-10-02. The listed applicant is Span-America Medical Systems, Inc.. The 510(k) number is K960188.

When did PRESSUREGUARD: SELECTCARE receive FDA 510(k) clearance?

PRESSUREGUARD: SELECTCARE received FDA 510(k) clearance on 1996-10-02, under 510(k) number K960188.

Who is the listed applicant for PRESSUREGUARD: SELECTCARE?

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: SELECTCARE?

The FDA product code for PRESSUREGUARD: SELECTCARE is FNM.

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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)K972486PRESSUREGUARD IVK961502LUBRICATING JELLY, LOW VISCOSITYK961159POWERED LOW AIR LOSS MATTRESS SYSTEMK960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEMK960189GEL-T CUSHION

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Related Devices (Code: FNM)

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)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, 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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