!M1
K-Number: K170607 · 2017-07-17
ApplicantSolutions For Tomorrow AB
Decision Date2017-07-17
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
!M1 is a medical device manufactured by Solutions For Tomorrow AB. It received FDA 510(k) clearance on 2017-07-17 under approval number K170607. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the !M1?
!M1 is a medical device that received FDA 510(k) clearance on 2017-07-17. It is manufactured by Solutions For Tomorrow AB. The 510(k) number is K170607.
When was !M1 approved by the FDA?
!M1 received FDA 510(k) clearance on 2017-07-17, under approval number K170607.
What company makes !M1?
!M1 is manufactured by Solutions For Tomorrow AB.
What is the FDA product code for !M1?
The FDA product code for !M1 is IZL.
Other Devices by Solutions For Tomorrow AB
Related Devices (Code: IZL)
K163063UC-5000 Mobile X-RaySource-Ray, Inc.
K162990Optima XR240amxGe Medical Systems, LLC
K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.
K162687Paragon 2Meridian Medical Systems, LLC
K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.
K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, 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.