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FDA 510(k)

PULMONEX DYNAMIC AIR THERAPY UNIT

K-Number: K950756 · 1995-05-30

ApplicantHill-Rom, Inc.
Decision Date1995-05-30
Product CodeIKZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PULMONEX DYNAMIC AIR THERAPY UNIT 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 1995-05-30 under 510(k) number K950756. The device is classified under product code IKZ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMONEX DYNAMIC AIR THERAPY UNIT?

PULMONEX DYNAMIC AIR THERAPY UNIT is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Hill-Rom, Inc.. The 510(k) number is K950756.

When did PULMONEX DYNAMIC AIR THERAPY UNIT receive FDA 510(k) clearance?

PULMONEX DYNAMIC AIR THERAPY UNIT received FDA 510(k) clearance on 1995-05-30, under 510(k) number K950756.

Who is the listed applicant for PULMONEX DYNAMIC AIR THERAPY UNIT?

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 PULMONEX DYNAMIC AIR THERAPY UNIT?

The FDA product code for PULMONEX DYNAMIC AIR THERAPY UNIT is IKZ.

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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: IKZ)

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.

K972486PRESSUREGUARD IVSpan-America Medical Systems, Inc.K972111RUMORS DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMGaymar Industries, Inc.K954671THE FREEDOM BEDProbed Medical Technologies, Inc.K950681MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPYInvacare Corp.K933964THE CRADLEThe Primal Energy Research Foundation

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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