Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SafeAir combi (SFR-combi-US)

K-Number: K223932 · 2023-04-26

ApplicantLina Medical Aps
Decision Date2023-04-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SafeAir combi (SFR-combi-US) is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K223932. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeAir combi (SFR-combi-US)?

SafeAir combi (SFR-combi-US) is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Lina Medical Aps. The 510(k) number is K223932.

When did SafeAir combi (SFR-combi-US) receive FDA 510(k) clearance?

SafeAir combi (SFR-combi-US) received FDA 510(k) clearance on 2023-04-26, under 510(k) number K223932.

Who is the listed applicant for SafeAir combi (SFR-combi-US)?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeAir combi (SFR-combi-US)?

The FDA product code for SafeAir combi (SFR-combi-US) is GEI.

Other records listing Lina Medical Aps 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.

K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)K221085LiNA OperaScope NeedleK193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording ModuleK182224SafeAir Smoke Evacuator compactK182354SafeAir Telescopic Smoke PencilK171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

View all 7 devices →

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑