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)

DHD METERED DOSE INHALER (MDI) SPACER

K-Number: K913326 · 1992-01-07

ApplicantDhd Diemolding Healthcare Div.
Decision Date1992-01-07
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DHD METERED DOSE INHALER (MDI) SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Dhd Diemolding Healthcare Div.. It received FDA 510(k) clearance on 1992-01-07 under 510(k) number K913326. 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 DHD METERED DOSE INHALER (MDI) SPACER?

DHD METERED DOSE INHALER (MDI) SPACER is a medical device that received FDA 510(k) clearance on 1992-01-07. The listed applicant is Dhd Diemolding Healthcare Div.. The 510(k) number is K913326.

When did DHD METERED DOSE INHALER (MDI) SPACER receive FDA 510(k) clearance?

DHD METERED DOSE INHALER (MDI) SPACER received FDA 510(k) clearance on 1992-01-07, under 510(k) number K913326.

Who is the listed applicant for DHD METERED DOSE INHALER (MDI) SPACER?

The FDA 510(k) record lists Dhd Diemolding Healthcare Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DHD METERED DOSE INHALER (MDI) SPACER?

The FDA product code for DHD METERED DOSE INHALER (MDI) SPACER 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 Dhd Diemolding Healthcare Div. 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.

K973532STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATORK970596DHD EMERALD PRODUCTK961973DHD ACE WITH MASK KITK953206DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)K945118EXPIRATORY BREATHING EXERCISERK944900THERAPEP

View all 11 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.

↑