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)

FLEXICAIR EXLIPSE PLUS

K-Number: K970295 · 1997-05-16

ApplicantHill-Rom, Inc.
Decision Date1997-05-16
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLEXICAIR EXLIPSE PLUS 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 1997-05-16 under 510(k) number K970295. 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 PLUS?

FLEXICAIR EXLIPSE PLUS is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Hill-Rom, Inc.. The 510(k) number is K970295.

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

FLEXICAIR EXLIPSE PLUS received FDA 510(k) clearance on 1997-05-16, under 510(k) number K970295.

Who is the listed applicant for FLEXICAIR EXLIPSE PLUS?

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 PLUS?

The FDA product code for FLEXICAIR EXLIPSE PLUS is IOQ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 34 devices →

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.

↑