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FDA 510(k)

PUL-TRON 100K PROFESSIONAL SPIROMETER

K-Number: K891672 · 1989-06-16

ApplicantAdvanced Medical Systems, Inc.
Decision Date1989-06-16
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PUL-TRON 100K PROFESSIONAL SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K891672. 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 PUL-TRON 100K PROFESSIONAL SPIROMETER?

PUL-TRON 100K PROFESSIONAL SPIROMETER is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K891672.

When did PUL-TRON 100K PROFESSIONAL SPIROMETER receive FDA 510(k) clearance?

PUL-TRON 100K PROFESSIONAL SPIROMETER received FDA 510(k) clearance on 1989-06-16, under 510(k) number K891672.

Who is the listed applicant for PUL-TRON 100K PROFESSIONAL SPIROMETER?

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

What is the FDA product code for PUL-TRON 100K PROFESSIONAL SPIROMETER?

The FDA product code for PUL-TRON 100K PROFESSIONAL SPIROMETER 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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