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FDA 510(k)

SpassageQ

K-Number: K230386 · 2023-06-15

ApplicantSpass, Inc.
Decision Date2023-06-15
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SpassageQ is the device name listed in this FDA 510(k) record. The listed applicant is Spass, Inc.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K230386. The device is classified under product code PLB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpassageQ?

SpassageQ is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Spass, Inc.. The 510(k) number is K230386.

When did SpassageQ receive FDA 510(k) clearance?

SpassageQ received FDA 510(k) clearance on 2023-06-15, under 510(k) number K230386.

Who is the listed applicant for SpassageQ?

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

What is the FDA product code for SpassageQ?

The FDA product code for SpassageQ is PLB.

Related Devices (Code: PLB)

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.

K240756AITRICS-VCAitrics Co., Ltd.K240558NAVOYCDSAlgodx ABK213423T3 Platform softwareEtiometry, Inc.K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.K152258T3 SoftwareEtiometry, Inc.

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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