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FDA 510(k)

PULMOSAL

K-Number: K130091 · 2013-03-13

ApplicantPharmacaribe
Decision Date2013-03-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMOSAL is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacaribe. It received FDA 510(k) clearance on 2013-03-13 under 510(k) number K130091. 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 PULMOSAL?

PULMOSAL is a medical device that received FDA 510(k) clearance on 2013-03-13. The listed applicant is Pharmacaribe. The 510(k) number is K130091.

When did PULMOSAL receive FDA 510(k) clearance?

PULMOSAL received FDA 510(k) clearance on 2013-03-13, under 510(k) number K130091.

Who is the listed applicant for PULMOSAL?

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

What is the FDA product code for PULMOSAL?

The FDA product code for PULMOSAL is CAF.

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Other records listing Pharmacaribe 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.

K101532NESSI OTC SPACERK101424PHARMACARIBE INHALED SALINE SOLUTIONSK091862NESSI SPACER

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

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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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