Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

I-5000

K-Number: K940662 · 1994-06-15

ApplicantSupport Systems Intl.
Decision Date1994-06-15
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

I-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Support Systems Intl.. It received FDA 510(k) clearance on 1994-06-15 under 510(k) number K940662. 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 I-5000?

I-5000 is a medical device that received FDA 510(k) clearance on 1994-06-15. The listed applicant is Support Systems Intl.. The 510(k) number is K940662.

When did I-5000 receive FDA 510(k) clearance?

I-5000 received FDA 510(k) clearance on 1994-06-15, under 510(k) number K940662.

Who is the listed applicant for I-5000?

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

What is the FDA product code for I-5000?

The FDA product code for I-5000 is IOQ.

Other records listing Support Systems Intl. 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.

K941610CLENSICAIR LOW AIRLOSS HYDROTHERAPYK922973RESTCUE CCK920382FLEXICAIR LOW AIRLOSS THERAPY UNITK920112CLINITRON C-II

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 ProductsK970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, 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.

↑