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FDA 510(k)

COOK MINI-INCUBATOR

K-Number: K983642 · 1999-02-01

ApplicantCook Ob/Gyn
Decision Date1999-02-01
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOK MINI-INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1999-02-01 under 510(k) number K983642. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK MINI-INCUBATOR?

COOK MINI-INCUBATOR is a medical device that received FDA 510(k) clearance on 1999-02-01. The listed applicant is Cook Ob/Gyn. The 510(k) number is K983642.

When did COOK MINI-INCUBATOR receive FDA 510(k) clearance?

COOK MINI-INCUBATOR received FDA 510(k) clearance on 1999-02-01, under 510(k) number K983642.

Who is the listed applicant for COOK MINI-INCUBATOR?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOK MINI-INCUBATOR?

The FDA product code for COOK MINI-INCUBATOR is MQG.

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Other records listing Cook Ob/Gyn as applicant

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Related Devices (Code: MQG)

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.

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)CooperSurgical, Inc.K260194Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company LimitedK242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.K173264EmbryoScope+Vitrolife A/S

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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