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)

SMDIA-1000

K-Number: K101953 · 2011-01-07

ApplicantSouthmedic, Inc.
Decision Date2011-01-07
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMDIA-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Southmedic, Inc.. It received FDA 510(k) clearance on 2011-01-07 under 510(k) number K101953. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMDIA-1000?

SMDIA-1000 is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Southmedic, Inc.. The 510(k) number is K101953.

When did SMDIA-1000 receive FDA 510(k) clearance?

SMDIA-1000 received FDA 510(k) clearance on 2011-01-07, under 510(k) number K101953.

Who is the listed applicant for SMDIA-1000?

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

What is the FDA product code for SMDIA-1000?

The FDA product code for SMDIA-1000 is CAF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Southmedic, Inc. 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.

K222511Oxy2ProK014211OXYARM CO2K945993VAPOFILK923265FUNNEL ADAPTORK863318AEROSOL-TK861839VAPOFIL

View all 9 devices →

Related Devices (Code: CAF)

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

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.

↑