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FDA 510(k)

MICROSPACER TM

K-Number: K903413 · 1990-10-09

ApplicantRespiratory Delivery Systems, Inc.
Decision Date1990-10-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROSPACER TM is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Delivery Systems, Inc.. It received FDA 510(k) clearance on 1990-10-09 under 510(k) number K903413. 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 MICROSPACER TM?

MICROSPACER TM is a medical device that received FDA 510(k) clearance on 1990-10-09. The listed applicant is Respiratory Delivery Systems, Inc.. The 510(k) number is K903413.

When did MICROSPACER TM receive FDA 510(k) clearance?

MICROSPACER TM received FDA 510(k) clearance on 1990-10-09, under 510(k) number K903413.

Who is the listed applicant for MICROSPACER TM?

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

What is the FDA product code for MICROSPACER TM?

The FDA product code for MICROSPACER TM 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 Respiratory Delivery Systems, 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.

K915211MICROCHAMBER

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

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