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FDA 510(k)

ONE-LUNG CPAP DEVICE

K-Number: K901728 · 1990-08-14

ApplicantVital Signs, Inc.
Decision Date1990-08-14
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ONE-LUNG CPAP DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K901728. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE-LUNG CPAP DEVICE?

ONE-LUNG CPAP DEVICE is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Vital Signs, Inc.. The 510(k) number is K901728.

When did ONE-LUNG CPAP DEVICE receive FDA 510(k) clearance?

ONE-LUNG CPAP DEVICE received FDA 510(k) clearance on 1990-08-14, under 510(k) number K901728.

Who is the listed applicant for ONE-LUNG CPAP DEVICE?

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

What is the FDA product code for ONE-LUNG CPAP DEVICE?

The FDA product code for ONE-LUNG CPAP DEVICE is BYE.

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.

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Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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