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FDA 510(k)

PHARMACARIBE INHALED SALINE SOLUTIONS

K-Number: K101424 · 2010-08-17

ApplicantPharmacaribe
Decision Date2010-08-17
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PHARMACARIBE INHALED SALINE SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacaribe. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K101424. 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 PHARMACARIBE INHALED SALINE SOLUTIONS?

PHARMACARIBE INHALED SALINE SOLUTIONS is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Pharmacaribe. The 510(k) number is K101424.

When did PHARMACARIBE INHALED SALINE SOLUTIONS receive FDA 510(k) clearance?

PHARMACARIBE INHALED SALINE SOLUTIONS received FDA 510(k) clearance on 2010-08-17, under 510(k) number K101424.

Who is the listed applicant for PHARMACARIBE INHALED SALINE SOLUTIONS?

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 PHARMACARIBE INHALED SALINE SOLUTIONS?

The FDA product code for PHARMACARIBE INHALED SALINE SOLUTIONS 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.

K130091PULMOSALK101532NESSI OTC SPACERK091862NESSI 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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