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FDA 510(k)

SPIROMETER MODEL NPB-500

K-Number: K980441 · 1998-04-30

ApplicantNellcor Puritan Bennett, Inc.
Decision Date1998-04-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETER MODEL NPB-500 is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K980441. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETER MODEL NPB-500?

SPIROMETER MODEL NPB-500 is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K980441.

When did SPIROMETER MODEL NPB-500 receive FDA 510(k) clearance?

SPIROMETER MODEL NPB-500 received FDA 510(k) clearance on 1998-04-30, under 510(k) number K980441.

Who is the listed applicant for SPIROMETER MODEL NPB-500?

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

What is the FDA product code for SPIROMETER MODEL NPB-500?

The FDA product code for SPIROMETER MODEL NPB-500 is BZG.

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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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