FDA 510(k)

PRESSURE GUARD SITE SELECT (A)

K-Number: K973169 · 1998-02-20

ApplicantSpan-America Medical Systems, Inc.

Decision Date1998-02-20

Product CodeFNM

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRESSURE GUARD SITE SELECT (A) 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 K973169. 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 PRESSURE GUARD SITE SELECT (A)?

PRESSURE GUARD SITE SELECT (A) 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 K973169.

When did PRESSURE GUARD SITE SELECT (A) receive FDA 510(k) clearance?

PRESSURE GUARD SITE SELECT (A) received FDA 510(k) clearance on 1998-02-20, under 510(k) number K973169.

Who is the listed applicant for PRESSURE GUARD SITE SELECT (A)?

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 PRESSURE GUARD SITE SELECT (A)?

The FDA product code for PRESSURE GUARD SITE SELECT (A) is FNM.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Span-America Medical Systems, Inc. as applicant

K972486PRESSUREGUARD IV K960188PRESSUREGUARD: SELECTCARE K961502LUBRICATING JELLY, LOW VISCOSITY K961159POWERED LOW AIR LOSS MATTRESS SYSTEM K960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM K960189GEL-T CUSHION

View all 19 devices →

Related Devices (Code: FNM)

K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of Kansas K974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.K955243BARIAIRKinetic Concepts, 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.