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FDA 510(k)

PeriFLEX

K-Number: K162611 · 2017-02-09

ApplicantSpiration, Inc.
Decision Date2017-02-09
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PeriFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Spiration, Inc.. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K162611. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeriFLEX?

PeriFLEX is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Spiration, Inc.. The 510(k) number is K162611.

When did PeriFLEX receive FDA 510(k) clearance?

PeriFLEX received FDA 510(k) clearance on 2017-02-09, under 510(k) number K162611.

Who is the listed applicant for PeriFLEX?

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

What is the FDA product code for PeriFLEX?

The FDA product code for PeriFLEX is EOQ.

Other records listing Spiration, Inc. as applicant

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Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

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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