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FDA 510(k)

STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR

K-Number: K973532 · 1998-03-19

ApplicantDhd Diemolding Healthcare Div.
Decision Date1998-03-19
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR 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 1998-03-19 under 510(k) number K973532. 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 STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR?

STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR is a medical device that received FDA 510(k) clearance on 1998-03-19. The listed applicant is Dhd Diemolding Healthcare Div.. The 510(k) number is K973532.

When did STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR receive FDA 510(k) clearance?

STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR received FDA 510(k) clearance on 1998-03-19, under 510(k) number K973532.

Who is the listed applicant for STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR?

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 STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR?

The FDA product code for STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR 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.

K970596DHD EMERALD PRODUCTK961973DHD ACE WITH MASK KITK953206DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)K945118EXPIRATORY BREATHING EXERCISERK944900THERAPEPK926301ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO

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Related Devices (Code: CAF)

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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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