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FDA 510(k)

EVA 15 Insufflator

K-Number: K193520 · 2020-07-23

ApplicantPalliare , Ltd.
Decision Date2020-07-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVA 15 Insufflator is the device name listed in this FDA 510(k) record. The listed applicant is Palliare , Ltd.. It received FDA 510(k) clearance on 2020-07-23 under 510(k) number K193520. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA 15 Insufflator?

EVA 15 Insufflator is a medical device that received FDA 510(k) clearance on 2020-07-23. The listed applicant is Palliare , Ltd.. The 510(k) number is K193520.

When did EVA 15 Insufflator receive FDA 510(k) clearance?

EVA 15 Insufflator received FDA 510(k) clearance on 2020-07-23, under 510(k) number K193520.

Who is the listed applicant for EVA 15 Insufflator?

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

What is the FDA product code for EVA 15 Insufflator?

The FDA product code for EVA 15 Insufflator is HIF.

Other records listing Palliare , Ltd. 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.

K232902EVA15 insufflatorK230474EVA5 InsufflatorK222901EVA15 insufflatorK202922END 200 Endoscopic TubesetK202799EVA15

Related Devices (Code: HIF)

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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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