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FDA 510(k)

ROADRUNNER, PEP THERAPY DEVICE

K-Number: K991561 · 1999-11-10

ApplicantDhd Healthcare Corp.
Decision Date1999-11-10
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROADRUNNER, PEP THERAPY DEVICE 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 1999-11-10 under 510(k) number K991561. 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 ROADRUNNER, PEP THERAPY DEVICE?

ROADRUNNER, PEP THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Dhd Healthcare Corp.. The 510(k) number is K991561.

When did ROADRUNNER, PEP THERAPY DEVICE receive FDA 510(k) clearance?

ROADRUNNER, PEP THERAPY DEVICE received FDA 510(k) clearance on 1999-11-10, under 510(k) number K991561.

Who is the listed applicant for ROADRUNNER, PEP THERAPY DEVICE?

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 ROADRUNNER, PEP THERAPY DEVICE?

The FDA product code for ROADRUNNER, PEP THERAPY DEVICE 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.

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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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