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FDA 510(k)

VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.

K-Number: K090840 · 2009-06-25

ApplicantVentlab Corp.
Decision Date2009-06-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. is the device name listed in this FDA 510(k) record. The listed applicant is Ventlab Corp.. It received FDA 510(k) clearance on 2009-06-25 under 510(k) number K090840. 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 VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.?

VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. is a medical device that received FDA 510(k) clearance on 2009-06-25. The listed applicant is Ventlab Corp.. The 510(k) number is K090840.

When did VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. receive FDA 510(k) clearance?

VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. received FDA 510(k) clearance on 2009-06-25, under 510(k) number K090840.

Who is the listed applicant for VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.?

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

What is the FDA product code for VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.?

The FDA product code for VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. is CAF.

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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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