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FDA 510(k)

BEAR EVC-100 CONTROLLER

K-Number: K882764 · 1988-09-30

ApplicantBear Medical Systems, Inc.
Decision Date1988-09-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BEAR EVC-100 CONTROLLER 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 1988-09-30 under 510(k) number K882764. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR EVC-100 CONTROLLER?

BEAR EVC-100 CONTROLLER is a medical device that received FDA 510(k) clearance on 1988-09-30. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K882764.

When did BEAR EVC-100 CONTROLLER receive FDA 510(k) clearance?

BEAR EVC-100 CONTROLLER received FDA 510(k) clearance on 1988-09-30, under 510(k) number K882764.

Who is the listed applicant for BEAR EVC-100 CONTROLLER?

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 EVC-100 CONTROLLER?

The FDA product code for BEAR EVC-100 CONTROLLER is CBK.

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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: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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