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FDA 510(k)

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510

K-Number: K080969 · 2008-07-25

Decision Date2008-07-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 is the device name listed in this FDA 510(k) record. The listed applicant is Medi Nuclear Corp., Inc.. It received FDA 510(k) clearance on 2008-07-25 under 510(k) number K080969. 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 HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510?

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K080969.

When did HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 receive FDA 510(k) clearance?

HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 received FDA 510(k) clearance on 2008-07-25, under 510(k) number K080969.

Who is the listed applicant for HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510?

The FDA 510(k) record lists Medi Nuclear Corp., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510?

The FDA product code for HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 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.

Other records listing Medi Nuclear Corp., Inc. 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.

View all 9 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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