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FDA 510(k)

BODIA TRACH-SAF DOUBLE SWIVEL

K-Number: K833372 · 1983-11-03

ApplicantSontek Industries, Inc.
Decision Date1983-11-03
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BODIA TRACH-SAF DOUBLE SWIVEL is the device name listed in this FDA 510(k) record. The listed applicant is Sontek Industries, Inc.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833372. 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 BODIA TRACH-SAF DOUBLE SWIVEL?

BODIA TRACH-SAF DOUBLE SWIVEL is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Sontek Industries, Inc.. The 510(k) number is K833372.

When did BODIA TRACH-SAF DOUBLE SWIVEL receive FDA 510(k) clearance?

BODIA TRACH-SAF DOUBLE SWIVEL received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833372.

Who is the listed applicant for BODIA TRACH-SAF DOUBLE SWIVEL?

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

What is the FDA product code for BODIA TRACH-SAF DOUBLE SWIVEL?

The FDA product code for BODIA TRACH-SAF DOUBLE SWIVEL is BZA.

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Other records listing Sontek Industries, 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.

K833374BITE-BLOCKK833373BODIA BRONCH-SAF DOUBLE SWIVELK833361TUBE-TITLEK813324BODAI SWIVEL YK812720BODAI PATIENT COMMUNICATORK811241BODAI SUCTION -SAFE 4

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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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