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FDA 510(k)

FLEX-ELBOW

K-Number: K912652 · 1991-10-10

ApplicantVital Signs, Inc.
Decision Date1991-10-10
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEX-ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1991-10-10 under 510(k) number K912652. 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 FLEX-ELBOW?

FLEX-ELBOW is a medical device that received FDA 510(k) clearance on 1991-10-10. The listed applicant is Vital Signs, Inc.. The 510(k) number is K912652.

When did FLEX-ELBOW receive FDA 510(k) clearance?

FLEX-ELBOW received FDA 510(k) clearance on 1991-10-10, under 510(k) number K912652.

Who is the listed applicant for FLEX-ELBOW?

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

What is the FDA product code for FLEX-ELBOW?

The FDA product code for FLEX-ELBOW is BZA.

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Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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