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FDA 510(k)

PNEUPAC VR1 AIR MIX

K-Number: K071527 · 2007-10-04

ApplicantSmiths Medical International , Ltd.
Decision Date2007-10-04
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEUPAC VR1 AIR MIX 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 2007-10-04 under 510(k) number K071527. 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 VR1 AIR MIX?

PNEUPAC VR1 AIR MIX is a medical device that received FDA 510(k) clearance on 2007-10-04. The listed applicant is Smiths Medical International , Ltd.. The 510(k) number is K071527.

When did PNEUPAC VR1 AIR MIX receive FDA 510(k) clearance?

PNEUPAC VR1 AIR MIX received FDA 510(k) clearance on 2007-10-04, under 510(k) number K071527.

Who is the listed applicant for PNEUPAC VR1 AIR MIX?

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 VR1 AIR MIX?

The FDA product code for PNEUPAC VR1 AIR MIX is BTL.

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 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 PLUSK051322PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS

Related Devices (Code: BTL)

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

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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