SafetiHeel, MediHeel, Novaplus
K-Number: K221604 · 2022-08-22
ApplicantNsp Tech Pte, Ltd.
Decision Date2022-08-22
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SafetiHeel, MediHeel, Novaplus is a medical device manufactured by Nsp Tech Pte, Ltd.. It received FDA 510(k) clearance on 2022-08-22 under approval number K221604. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SafetiHeel, MediHeel, Novaplus?
SafetiHeel, MediHeel, Novaplus is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Nsp Tech Pte, Ltd.. The 510(k) number is K221604.
When was SafetiHeel, MediHeel, Novaplus approved by the FDA?
SafetiHeel, MediHeel, Novaplus received FDA 510(k) clearance on 2022-08-22, under approval number K221604.
What company makes SafetiHeel, MediHeel, Novaplus?
SafetiHeel, MediHeel, Novaplus is manufactured by Nsp Tech Pte, Ltd..
What is the FDA product code for SafetiHeel, MediHeel, Novaplus?
The FDA product code for SafetiHeel, MediHeel, Novaplus is FMK.
Other Devices by Nsp Tech Pte, Ltd.
Related Devices (Code: FMK)
K153670Genteel Lancing DeviceGenteel, LLC
K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd.
K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.
K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd.
K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc.
K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel LancetsBecton, Dickinson and Company
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.