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FDA 510(k)

FLEXICAIR EXLIPSE

K-Number: K951001 · 1995-06-27

ApplicantHill-Rom, Inc.
Decision Date1995-06-27
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLEXICAIR EXLIPSE is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom, Inc.. It received FDA 510(k) clearance on 1995-06-27 under 510(k) number K951001. 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 FLEXICAIR EXLIPSE?

FLEXICAIR EXLIPSE is a medical device that received FDA 510(k) clearance on 1995-06-27. The listed applicant is Hill-Rom, Inc.. The 510(k) number is K951001.

When did FLEXICAIR EXLIPSE receive FDA 510(k) clearance?

FLEXICAIR EXLIPSE received FDA 510(k) clearance on 1995-06-27, under 510(k) number K951001.

Who is the listed applicant for FLEXICAIR EXLIPSE?

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

What is the FDA product code for FLEXICAIR EXLIPSE?

The FDA product code for FLEXICAIR EXLIPSE is IOQ.

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Other records listing Hill-Rom, 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.

K260211Dashboard (P007000)K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor ActivationK180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor ActivationK013709HILL-ROM PRIMAVIEW MONITOR SYSTEMK973705CONTOR TABLE SURFACEK981081BRIGHTSTAR

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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

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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