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FDA 510(k)

BEAR NICU-1

K-Number: K853346 · 1985-09-11

ApplicantBear Medical Systems, Inc.
Decision Date1985-09-11
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BEAR NICU-1 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 1985-09-11 under 510(k) number K853346. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR NICU-1?

BEAR NICU-1 is a medical device that received FDA 510(k) clearance on 1985-09-11. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K853346.

When did BEAR NICU-1 receive FDA 510(k) clearance?

BEAR NICU-1 received FDA 510(k) clearance on 1985-09-11, under 510(k) number K853346.

Who is the listed applicant for BEAR NICU-1?

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 NICU-1?

The FDA product code for BEAR NICU-1 is BZK.

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: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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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