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FDA 510(k)

PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS

K-Number: K051322 · 2005-08-05

ApplicantSmiths Medical International , Ltd.
Decision Date2005-08-05
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical International , Ltd.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K051322. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS?

PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Smiths Medical International , Ltd.. The 510(k) number is K051322.

When did PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS receive FDA 510(k) clearance?

PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS received FDA 510(k) clearance on 2005-08-05, under 510(k) number K051322.

Who is the listed applicant for PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS?

The FDA 510(k) record lists Smiths Medical International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS?

The FDA product code for PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS is BTL.

Related Clinical Trials

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Other records listing Smiths Medical International , Ltd. 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.

K123957PNEUPAC PARAPAC PLUSK071527PNEUPAC VR1 AIR MIX

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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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