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FDA 510(k)

DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)

K-Number: K953206 · 1995-08-28

ApplicantDhd Diemolding Healthcare Div.
Decision Date1995-08-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) 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 1995-08-28 under 510(k) number K953206. 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 (MODIFICATION)?

DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Dhd Diemolding Healthcare Div.. The 510(k) number is K953206.

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

DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) received FDA 510(k) clearance on 1995-08-28, under 510(k) number K953206.

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

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 (MODIFICATION)?

The FDA product code for DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) is CAF.

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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 KITK945118EXPIRATORY BREATHING EXERCISERK944900THERAPEPK926301ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO

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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.

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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.

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