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FDA 510(k)

STRAP, HEAD, GAS MASK

K-Number: K914335 · 1992-04-02

ApplicantVital Signs, Inc.
Decision Date1992-04-02
Product CodeBTK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STRAP, HEAD, GAS MASK 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 1992-04-02 under 510(k) number K914335. The device is classified under product code BTK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAP, HEAD, GAS MASK?

STRAP, HEAD, GAS MASK is a medical device that received FDA 510(k) clearance on 1992-04-02. The listed applicant is Vital Signs, Inc.. The 510(k) number is K914335.

When did STRAP, HEAD, GAS MASK receive FDA 510(k) clearance?

STRAP, HEAD, GAS MASK received FDA 510(k) clearance on 1992-04-02, under 510(k) number K914335.

Who is the listed applicant for STRAP, HEAD, GAS MASK?

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 STRAP, HEAD, GAS MASK?

The FDA product code for STRAP, HEAD, GAS MASK is BTK.

Related Clinical Trials

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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: BTK)

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.

K944949GENERAL ANESTHESIA SYSTEMVital Signs, Inc.K854537HEADSTRAPLife Design Systems, Inc.K853573MEDIPART FACE MASK HEADSTRAP MP-9100Medipart Jerry AlexanderK831008HEAD STRAPMedovations, Inc.K810991HEADSTRAPRespironics, 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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