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FDA 510(k)

COOK TEST TUBE HEATER

K-Number: K983609 · 1998-12-16

ApplicantCook Ob/Gyn
Decision Date1998-12-16
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOK TEST TUBE HEATER 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 1998-12-16 under 510(k) number K983609. 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 TEST TUBE HEATER?

COOK TEST TUBE HEATER is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Cook Ob/Gyn. The 510(k) number is K983609.

When did COOK TEST TUBE HEATER receive FDA 510(k) clearance?

COOK TEST TUBE HEATER received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983609.

Who is the listed applicant for COOK TEST TUBE HEATER?

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 TEST TUBE HEATER?

The FDA product code for COOK TEST TUBE HEATER is MQG.

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Other records listing Cook Ob/Gyn 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.

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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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