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FDA 510(k)

KRYO ART CONTROLLED RATE FREEZER

K-Number: K032086 · 2004-03-19

ApplicantPlaner Plc
Decision Date2004-03-19
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KRYO ART CONTROLLED RATE FREEZER is the device name listed in this FDA 510(k) record. The listed applicant is Planer Plc. It received FDA 510(k) clearance on 2004-03-19 under 510(k) number K032086. 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 KRYO ART CONTROLLED RATE FREEZER?

KRYO ART CONTROLLED RATE FREEZER is a medical device that received FDA 510(k) clearance on 2004-03-19. The listed applicant is Planer Plc. The 510(k) number is K032086.

When did KRYO ART CONTROLLED RATE FREEZER receive FDA 510(k) clearance?

KRYO ART CONTROLLED RATE FREEZER received FDA 510(k) clearance on 2004-03-19, under 510(k) number K032086.

Who is the listed applicant for KRYO ART CONTROLLED RATE FREEZER?

The FDA 510(k) record lists Planer Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KRYO ART CONTROLLED RATE FREEZER?

The FDA product code for KRYO ART CONTROLLED RATE FREEZER is MQG.

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Other records listing Planer Plc 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.

K121566PLANER BT37 INCUBATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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