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FDA 510(k)

PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT

K-Number: K884525 · 1988-12-16

ApplicantIntertech/Ohio
Decision Date1988-12-16
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT is the device name listed in this FDA 510(k) record. The listed applicant is Intertech/Ohio. It received FDA 510(k) clearance on 1988-12-16 under 510(k) number K884525. 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 PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT?

PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Intertech/Ohio. The 510(k) number is K884525.

When did PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT receive FDA 510(k) clearance?

PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT received FDA 510(k) clearance on 1988-12-16, under 510(k) number K884525.

Who is the listed applicant for PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT?

The FDA 510(k) record lists Intertech/Ohio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT?

The FDA product code for PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT is BZO.

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Other records listing Intertech/Ohio 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.

K895144INTERTECH METERED DOSE ELBOWK890346INTERTECH UNIVERSAL HYDROPHOBIC FILTERK884526ADULT RESUSCITATOR WITH MASK AND FILTERK882204RESUSCITATOR VALVE ASSEMBLY W/FILTERK880394FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATORK863033PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS

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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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