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FDA 510(k)

NEONATAL VENTILATOR CIRCUIT

K-Number: K903083 · 1990-12-27

ApplicantHudson Respiratory Care, Inc.
Decision Date1990-12-27
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEONATAL VENTILATOR CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 1990-12-27 under 510(k) number K903083. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL VENTILATOR CIRCUIT?

NEONATAL VENTILATOR CIRCUIT is a medical device that received FDA 510(k) clearance on 1990-12-27. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K903083.

When did NEONATAL VENTILATOR CIRCUIT receive FDA 510(k) clearance?

NEONATAL VENTILATOR CIRCUIT received FDA 510(k) clearance on 1990-12-27, under 510(k) number K903083.

Who is the listed applicant for NEONATAL VENTILATOR CIRCUIT?

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

What is the FDA product code for NEONATAL VENTILATOR CIRCUIT?

The FDA product code for NEONATAL VENTILATOR CIRCUIT is BZO.

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Other records listing Hudson Respiratory Care, 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.

K031383MODEL 780K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIK011134OXYGEN SUPPLY TUBING, MODEL 1115K010402SMOOTH-FLO CIRCUITK001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43

View all 15 devices →

Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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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