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FDA 510(k)

INTERTECH METERED DOSE ELBOW

K-Number: K895144 · 1989-10-19

ApplicantIntertech/Ohio
Decision Date1989-10-19
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTERTECH METERED DOSE ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Intertech/Ohio. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895144. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERTECH METERED DOSE ELBOW?

INTERTECH METERED DOSE ELBOW is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Intertech/Ohio. The 510(k) number is K895144.

When did INTERTECH METERED DOSE ELBOW receive FDA 510(k) clearance?

INTERTECH METERED DOSE ELBOW received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895144.

Who is the listed applicant for INTERTECH METERED DOSE ELBOW?

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 INTERTECH METERED DOSE ELBOW?

The FDA product code for INTERTECH METERED DOSE ELBOW is BZA.

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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.

K890346INTERTECH UNIVERSAL HYDROPHOBIC FILTERK884525PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORTK884526ADULT 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: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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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