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FDA 510(k)

SMI 3000 AIRBED

K-Number: K883192 · 1988-10-26

ApplicantSmi Patientcare, Inc.
Decision Date1988-10-26
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SMI 3000 AIRBED is the device name listed in this FDA 510(k) record. The listed applicant is Smi Patientcare, Inc.. It received FDA 510(k) clearance on 1988-10-26 under 510(k) number K883192. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMI 3000 AIRBED?

SMI 3000 AIRBED is a medical device that received FDA 510(k) clearance on 1988-10-26. The listed applicant is Smi Patientcare, Inc.. The 510(k) number is K883192.

When did SMI 3000 AIRBED receive FDA 510(k) clearance?

SMI 3000 AIRBED received FDA 510(k) clearance on 1988-10-26, under 510(k) number K883192.

Who is the listed applicant for SMI 3000 AIRBED?

The FDA 510(k) record lists Smi Patientcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMI 3000 AIRBED?

The FDA product code for SMI 3000 AIRBED is IOQ.

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Related Devices (Code: IOQ)

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.

K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-RomK973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist ProductsK970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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