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FDA 510(k)

ACAPELLA

K-Number: K002768 · 2000-12-05

ApplicantDhd Healthcare Corp.
Decision Date2000-12-05
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACAPELLA is the device name listed in this FDA 510(k) record. The listed applicant is Dhd Healthcare Corp.. It received FDA 510(k) clearance on 2000-12-05 under 510(k) number K002768. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACAPELLA?

ACAPELLA is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Dhd Healthcare Corp.. The 510(k) number is K002768.

When did ACAPELLA receive FDA 510(k) clearance?

ACAPELLA received FDA 510(k) clearance on 2000-12-05, under 510(k) number K002768.

Who is the listed applicant for ACAPELLA?

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

What is the FDA product code for ACAPELLA?

The FDA product code for ACAPELLA is BWF.

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Other records listing Dhd Healthcare Corp. 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.

K040718TRUSTK003146CLINIFLO INCENTIVE SPIROMETERK991561ROADRUNNER, PEP THERAPY DEVICEK991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEK983467THERAPEPK980662LICHEN, BACTERIAL IN LINE BREATHING FILTER

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Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, 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.

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