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FDA 510(k)

HYPER-HYPOTHERMIA UNIT HYPO 10-200

K-Number: K831677 · 1983-07-18

ApplicantGambro, Inc.
Decision Date1983-07-18
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYPER-HYPOTHERMIA UNIT HYPO 10-200 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K831677. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPER-HYPOTHERMIA UNIT HYPO 10-200?

HYPER-HYPOTHERMIA UNIT HYPO 10-200 is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Gambro, Inc.. The 510(k) number is K831677.

When did HYPER-HYPOTHERMIA UNIT HYPO 10-200 receive FDA 510(k) clearance?

HYPER-HYPOTHERMIA UNIT HYPO 10-200 received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831677.

Who is the listed applicant for HYPER-HYPOTHERMIA UNIT HYPO 10-200?

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

What is the FDA product code for HYPER-HYPOTHERMIA UNIT HYPO 10-200?

The FDA product code for HYPER-HYPOTHERMIA UNIT HYPO 10-200 is DWC.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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Related Devices (Code: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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