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FDA 510(k)

VIDA PULMONARY WORKSTATION 2 (PW2)

K-Number: K083227 · 2008-11-18

ApplicantVida Diagnostics, Inc.
Decision Date2008-11-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIDA PULMONARY WORKSTATION 2 (PW2) is the device name listed in this FDA 510(k) record. The listed applicant is Vida Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-11-18 under 510(k) number K083227. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDA PULMONARY WORKSTATION 2 (PW2)?

VIDA PULMONARY WORKSTATION 2 (PW2) is a medical device that received FDA 510(k) clearance on 2008-11-18. The listed applicant is Vida Diagnostics, Inc.. The 510(k) number is K083227.

When did VIDA PULMONARY WORKSTATION 2 (PW2) receive FDA 510(k) clearance?

VIDA PULMONARY WORKSTATION 2 (PW2) received FDA 510(k) clearance on 2008-11-18, under 510(k) number K083227.

Who is the listed applicant for VIDA PULMONARY WORKSTATION 2 (PW2)?

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

What is the FDA product code for VIDA PULMONARY WORKSTATION 2 (PW2)?

The FDA product code for VIDA PULMONARY WORKSTATION 2 (PW2) is JAK.

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.

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Other records listing Vida Diagnostics, 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.

K200990VIDAvision

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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