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FDA 510(k)

PLANER BT37 INCUBATOR

K-Number: K121566 · 2012-11-29

ApplicantPlaner Plc
Decision Date2012-11-29
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PLANER BT37 INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Planer Plc. It received FDA 510(k) clearance on 2012-11-29 under 510(k) number K121566. 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 PLANER BT37 INCUBATOR?

PLANER BT37 INCUBATOR is a medical device that received FDA 510(k) clearance on 2012-11-29. The listed applicant is Planer Plc. The 510(k) number is K121566.

When did PLANER BT37 INCUBATOR receive FDA 510(k) clearance?

PLANER BT37 INCUBATOR received FDA 510(k) clearance on 2012-11-29, under 510(k) number K121566.

Who is the listed applicant for PLANER BT37 INCUBATOR?

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 PLANER BT37 INCUBATOR?

The FDA product code for PLANER BT37 INCUBATOR 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.

K032086KRYO ART CONTROLLED RATE FREEZER

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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