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FDA 510(k)

HI FLEX D-700 MODULAR BUBBLE OXYGENA-

K-Number: K830639 · 1983-05-25

ApplicantElectromedics, Inc.
Decision Date1983-05-25
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI FLEX D-700 MODULAR BUBBLE OXYGENA- is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1983-05-25 under 510(k) number K830639. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI FLEX D-700 MODULAR BUBBLE OXYGENA-?

HI FLEX D-700 MODULAR BUBBLE OXYGENA- is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is Electromedics, Inc.. The 510(k) number is K830639.

When did HI FLEX D-700 MODULAR BUBBLE OXYGENA- receive FDA 510(k) clearance?

HI FLEX D-700 MODULAR BUBBLE OXYGENA- received FDA 510(k) clearance on 1983-05-25, under 510(k) number K830639.

Who is the listed applicant for HI FLEX D-700 MODULAR BUBBLE OXYGENA-?

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

What is the FDA product code for HI FLEX D-700 MODULAR BUBBLE OXYGENA-?

The FDA product code for HI FLEX D-700 MODULAR BUBBLE OXYGENA- is DTZ.

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Related Devices (Code: DTZ)

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.

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.LK253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L

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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