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FDA 510(k)

SWIVEL ADAPTOR W/ALARM PORT

K-Number: K840015 · 1984-01-17

ApplicantPortex, Inc.
Decision Date1984-01-17
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SWIVEL ADAPTOR W/ALARM PORT is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 1984-01-17 under 510(k) number K840015. 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 SWIVEL ADAPTOR W/ALARM PORT?

SWIVEL ADAPTOR W/ALARM PORT is a medical device that received FDA 510(k) clearance on 1984-01-17. The listed applicant is Portex, Inc.. The 510(k) number is K840015.

When did SWIVEL ADAPTOR W/ALARM PORT receive FDA 510(k) clearance?

SWIVEL ADAPTOR W/ALARM PORT received FDA 510(k) clearance on 1984-01-17, under 510(k) number K840015.

Who is the listed applicant for SWIVEL ADAPTOR W/ALARM PORT?

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

What is the FDA product code for SWIVEL ADAPTOR W/ALARM PORT?

The FDA product code for SWIVEL ADAPTOR W/ALARM PORT is BZA.

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Other records listing Portex, Inc. as applicant

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K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERK031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITK0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORK0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXK014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEK873992LARYNGECTOMY TUBE

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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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