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FDA 510(k)

BEAR VENTI--VOICE

K-Number: K834555 · 1984-01-24

ApplicantBear Medical Systems, Inc.
Decision Date1984-01-24
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEAR VENTI--VOICE is the device name listed in this FDA 510(k) record. The listed applicant is Bear Medical Systems, Inc.. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K834555. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR VENTI--VOICE?

BEAR VENTI--VOICE is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K834555.

When did BEAR VENTI--VOICE receive FDA 510(k) clearance?

BEAR VENTI--VOICE received FDA 510(k) clearance on 1984-01-24, under 510(k) number K834555.

Who is the listed applicant for BEAR VENTI--VOICE?

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

What is the FDA product code for BEAR VENTI--VOICE?

The FDA product code for BEAR VENTI--VOICE is ESE.

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Other records listing Bear Medical Systems, 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.

K992788BEAR CUB 750 PSVK983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBEK912619BEAR 7 VENTILATORK900637BEAR CEM CONTROLLERK896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLYK893034VHS 820 HUMIDIFIER, MODIFICATION

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Related Devices (Code: ESE)

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.

K934483NU-VOIS BATTERY POWERED ARTIFICIAL LARYNXMountain Precision Mfg. Ltd. Co.K931371DENRICK SPEECH AID (DR-1)Denrick Corp.K923648LECTRO-LARYNXBruce Medical SupplyK914816AMERICAN ARTIFICIAL LARYNXUltravoice, Ltd.K901503ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEMStanton Magnetics, Inc.K860992VOX COMPANIONBloomfield Research and Development, 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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