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FDA 510(k)

BEAR CEM CONTROLLER

K-Number: K900637 · 1990-08-03

ApplicantBear Medical Systems, Inc.
Decision Date1990-08-03
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BEAR CEM 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 1990-08-03 under 510(k) number K900637. 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 CEM CONTROLLER?

BEAR CEM CONTROLLER is a medical device that received FDA 510(k) clearance on 1990-08-03. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K900637.

When did BEAR CEM CONTROLLER receive FDA 510(k) clearance?

BEAR CEM CONTROLLER received FDA 510(k) clearance on 1990-08-03, under 510(k) number K900637.

Who is the listed applicant for BEAR CEM 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 CEM CONTROLLER?

The FDA product code for BEAR CEM 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 VENTILATORK896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLYK893034VHS 820 HUMIDIFIER, MODIFICATIONK890724MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR

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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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