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FDA 510(k)

CLINITRON RITE-HITE

K-Number: K964223 · 1997-05-28

ApplicantHill-Rom, Inc.
Decision Date1997-05-28
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CLINITRON RITE-HITE 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 1997-05-28 under 510(k) number K964223. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINITRON RITE-HITE?

CLINITRON RITE-HITE is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Hill-Rom, Inc.. The 510(k) number is K964223.

When did CLINITRON RITE-HITE receive FDA 510(k) clearance?

CLINITRON RITE-HITE received FDA 510(k) clearance on 1997-05-28, under 510(k) number K964223.

Who is the listed applicant for CLINITRON RITE-HITE?

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 CLINITRON RITE-HITE?

The FDA product code for CLINITRON RITE-HITE is INX.

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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: INX)

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.

K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K943385CLINITRON ELEXISSsi Medical Services, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, Inc.K924973DYLNAMEDICS A.S.A.P.Dynamedics, 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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